The Company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, Brimonidine Tartrate Ophthalmic Solution, 0.1%, Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg, Erythromycin Tablets USP, 250 mg and 500 mg, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg.

Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC., is to manage the symptoms of psychotic disorders and treatment of schizophrenia, control nausea and vomiting, relief of restlessness and apprehension before surgery, acute intermittent porphyria, adjunct in the treatment of tetanus, to control the manifestations of the manic type of manic-depressive illness and for relief of intractable hiccups.

Brimonidine Tartrate Ophthalmic Solution, 0.1% with the brand name Alphagan P Ophthalmic Solution is from the innovator AbbVie, Inc. The medication is indicated to lower elevated intraocular pressure (IOP) in patients suffering with open-angle glaucoma or ocular hypertension.

Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg by Takeda Pharmaceuticals U.S.A., Inc. and with brand name Intuniv Extended-Release Tablets is indicated for individuals suffering from Attention Deficit Hyperactivity Disorder (ADHD). The tablets can be used alone or alongside stimulant medications.

Erythromycin Tablets USP, 250 mg and 500 mg by Azurity Pharmaceuticals, Inc. is for treatment of various infections caused by certain microorganisms.

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% by AbbVie,Inc. is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The brand name for the product is Combigan Ophthalmic Solution.

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg with the brand name Librax Capsules by Bausch Health US, LLC. are indicated to control emotional and physical factors that can cause gastrointestinal disorders. These capsules may also be used as additional treatments to help in peptic ulcer and in irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Read also: Alembic Pharma successfully completes ANVISA, Brazil GMP audit for API-III facility at Karakhadi

The combination of AbbVie's Venclyxto and a steroid dexamethasone was being tested in patients with a type of relapsed multiple myeloma who had received two or more prior treatments.

AbbVie's combination improved the median progression-free survival period to 9.9 months, compared with 5.8 months for a combination of Bristol-Myers Squibb's Pomalyst and dexamethasone, but the results were not statistically significant.

The company said 62% of patients treated with the combination therapy showed complete disappearance of tumors or reduction in tumor size, compared with 35% of patients treated with the Pomalyst-dexamethasone combination.

While the trial did not meet its primary endpoint, the company is planning to discuss the data with health authorities in the near future given the potentially favorable trends, Mariana Stirner, AbbVie's head of oncology and hematology therapeutic areas, said in the company statement.

Multiple myeloma, the second-most common blood cancer in the world, starts in plasma cells in bone marrow and ultimately disrupts the production of normal blood cells.

Venclyxto, which is approved in the U.S. to treat two other types of blood cancer, brought in revenues of $2.01 billion in 2022.

It is jointly commercialized by AbbVie and Roche unit Genentech in the U.S. and by AbbVie outside the country.

Read also: Abbvie executive Patrick Horber appointed as Novartis's President, International

Shareholders also approved an ordinary capital decrease of the share capital of Novartis AG in the amount of the share capital of Sandoz. This is to achieve tax neutrality of the Spin-off for Swiss withholding tax purposes and for income tax purposes for Swiss domiciled shareholders holding the shares as private assets.

This decision follows the announcement in August 2022 that Novartis intended to separate the Sandoz business to create an independent company by way of a 100% Spin-off.

"Novartis is confident that the Spin-off is in the best interests of shareholders, creating a European champion and a global leader in Generics and Biosimilars, and a more focused Novartis. The Spin-off is planned to occur on or around October 4, 2023," the company stated in a release.

The Spin-off will be implemented through the distribution of a dividend-in-kind of Sandoz shares to Novartis shareholders, and of Sandoz American Depositary Receipts (ADRs) to Novartis ADR holders.

Novartis shareholders and Novartis ADR holders will receive:

• 1 Sandoz Share for every 5 Novartis Shares
• 1 Sandoz ADR for every 5 Novartis ADRs

The Spin-off is expected to be tax neutral for Swiss tax and US federal income tax purposes.

“We welcome the decision by our shareholders to approve the Spin-off of our Generics and Biosimilars business, Sandoz, to create an independent company listed on the SIX Swiss Exchange”, said Joerg Reinhardt, Chair of the Board of Directors of Novartis. “With this step, both Sandoz and Novartis will be able to optimize management focus, allocate capital on business priorities, and be in a better position to create sustainable shareholder value in the future.”

"Sandoz is planned to be listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US. The ADRs will not be listed on a US national securities exchange. In addition to Novartis shareholder approval, completion of the proposed Sandoz Spin-off is subject to satisfaction of certain conditions, including receipt of the necessary approvals for the listing of the Sandoz shares, no event outside of the control of Novartis preventing the Spin-off and no material adverse change. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed," the release further stated.

Read also: Abbvie executive Patrick Horber appointed as Novartis's President, International

Patrick Horber, M.D., currently Senior Vice President and President, Immunology at AbbVie has been appointed as President, International, effective later this year, reporting to Vas Narasimhan, M.D., CEO of Novartis. Dr. Horber will become a member of the ECN. Mukul Mehta, Chief Financial Officer, International, will lead the unit ad-interim until Dr. Horber assumes the role.

“I leave Novartis with a strong sense of pride and accomplishment in how we have delivered on our purpose,” Marie-France Tschudin said. “My deep esteem and gratitude go to the Novartis colleagues around the globe for their trust, hard work, and relentless efforts in getting patients the treatments they need, faster.”

Vas Narasimhan said: “I want to thank Marie-France for her extraordinary leadership during her nearly seven years at Novartis. She has been integral to reimagining our commercial model and the way we deliver innovative medicines to patients around the world. Marie-France has led her teams to remarkable growth. The impact she has had on our business, on our people, and on patients around the world will be long-lasting. I wish her the very best as she pursues her next chapter.”

“I look forward to welcoming Patrick to Novartis. He is a proven leader with deep experience enabling commercial performance on a global scale, and I am confident he will catalyze our growth journey as Novartis enters our next chapter as a fully focused innovative medicines company.”

Patrick Horber said, "As a Swiss medical doctor, it is a privilege to join Novartis—a pillar of global biomedical innovation and scientific progress. I look forward to working alongside our teams to reimagine medicine for and with patients around the globe.”

Dr. Horber holds a M.D. from the University of Zurich. He is a native of Switzerland with over 20 years of experience in the biopharma sector and a deep understanding of the global pharmaceutical market. In his latest role as Senior Vice President and President, Immunology, at AbbVie, Dr. Horber was responsible for their Immunology Business Unit, leading the Global Strategy and U.S. execution including Global Commercial Development. Prior to this role he has served in a variety of leadership and general management positions in the US and Europe.

Read also: Novartis concludes acquisition of Chinook Therapeutics

The approval makes AQUIPTA the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment in the European Union for the preventive treatment of both chronic and episodic migraine.

Chronic migraine is characterized by 15 or more headache days per month and at least eight migraine days, while episodic migraine refers to people with migraine who have less than 15 headache days per month. People living with migraine may experience frequent disabling attacks that prevent them from performing daily activities and can significantly affect their quality of life. This debilitating disease also imposes both a social and financial burden for people living with migraine and health care systems. In Europe, migraine is estimated to cost the economy €50 billion annually due to reduced productivity and workdays lost.

"The European Commission approval of AQUIPTA is a significant milestone for people suffering from four or more migraine days per month as it provides a once-daily treatment option that can reduce the number of migraine days and the associated pain they experience," said Roopal Thakkar, SVP, Development and Regulatory Affairs, Chief Medical Officer, AbbVie. "With this approval, AbbVie can help meet additional migraine patient needs through our enhanced portfolio of treatment options across migraine frequencies, including episodic and chronic migraine."

The approval of AQUIPTA is supported by data from two pivotal Phase 3 studies, PROGRESS and ADVANCE, which evaluated 60 mg once-daily (QD) AQUIPTA in adult patients with chronic migraine and episodic migraine, respectively. Both studies met their primary endpoint of a statistically significant reduction in mean monthly migraine days (MMDs), compared to placebo across the 12-week treatment period. Additionally, statistically significant improvements were seen in all secondary endpoints with AQUIPTA 60 mg QD, with a key secondary endpoint measuring the proportion of patients that achieved at least a 50% reduction in MMDs across the 12-week treatment period.

In the PROGRESS study, the changes from baseline in MMDs was a reduction of 6.8 days for AQUIPTA 60 mg QD and a reduction of 5.1 days for placebo (p=0.0024). The study demonstrated that 40% of patients treated with AQUIPTA 60 mg QD achieved at least a 50% reduction in MMDs, compared to 27% of patients in the placebo arm (p=0.0024).5 In the ADVANCE study, the changes from baseline in MMDs was a reduction of 4.1 days for AQUIPTA 60 mg QD and a reduction of 2.5 days for placebo (p≤0.001). The study also demonstrated that 59% of patients treated with AQUIPTA 60 mg QD achieved at least a 50% reduction in MMDs, compared to 29% of patients in the placebo arm (p≤0.0001).6

"Migraine is a neurological disease that causes recurrent pain and other migraine-associated symptoms, with attacks that can last several hours to days, leading to missed life opportunities," said Prof. Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall d'Hebron Hospital and Institute of Research, Spain. "The pivotal Phase 3 studies demonstrated AQUIPTA provides significant and sustained reduction of mean monthly migraine days. This allows people to experience relief with a simple to take once-daily tablet, including those who have had an insufficient response to prior preventative migraine treatments."

Atogepant is approved in the United States for both chronic and episodic migraine and in Canada for episodic migraine under the brand name QULIPTA®.

Read also: Lupin receives over Rs 205 crore from AbbVie for meeting key product development milestone

A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe.

If the new applications are approved, EDURANT, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.

“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”

The expanded pediatric applications are supported by data from the Phase 2 PAINT and PICTURE studies, which showed that EDURANT, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.

In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.

Read also: Phase 3 trial of Rybrevant plus chemotherapy in lung cancer meets primary endpoint: Janssen

Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses

Osaka: Takeda has announced that the Company has voluntarily withdrawn the U.S. Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003, following discussions with the U.S. Food and Drug Administration (FDA) on aspects of data collection, which cannot be addressed within the current BLA review cycle.

The future plan for TAK-003 in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico. The vaccine is approved in multiple endemic and non-endemic countries, with more approvals expected over the coming years.

“Our clinical program was designed to account for the complex global nature of dengue, and data from our 4.5-year trial has built confidence in TAK-003’s ability to help provide long-term protection against dengue, with a positive benefit and risk profile regardless of baseline serostatus,” said Gary Dubin, M.D., president of Takeda’s Vaccines Business Unit. “The urgent global need to combat the growing burden of dengue remains, and we will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.”

The efficacy and safety profiles of TAK-003 have been demonstrated through a robust clinical trial program, including a 4.5-year Phase 3 study of over 20,000 children and adolescents living in eight dengue endemic areas. The study was designed per World Health Organization (WHO) guidance for a second-generation dengue vaccine, and it considered the need to achieve high levels of subject retention and protocol compliance in endemic regions.

Last year, TAK-003 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) after going through the EU-M4all process, a parallel review of the vaccine for use in the EU and participating dengue endemic countries around the world. The vaccine has since been approved in the EU, United Kingdom, Brazil, Argentina, Indonesia, and Thailand.

Dengue is a global public health crisis and further prevention measures are needed to support the millions of individuals around the world exposed to dengue.

Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.

Read also: Taked Dengue Tetravalent Vaccine QDENGA gets European Commission nod

The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

“We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, Managing Director, Lupin.

Read also: USFDA inspection: Lupin gets 10 observations for Pithampur facility

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Read also: Lupin CSR arm, Maharashtra Govt collaborate to address growing prevalence of cardiovascular diseases, COPD

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin gets USD 25 million from AbbVie for novel MALT1 inhibitor program to treat hematological cancers

Mumbai: Global pharma major Lupin Limited today announced that
it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for
its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg.

The product is a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare
Company.

Dolutegravir is an antiretroviral medication used, together with other medications, for the treatment of HIV/AIDS.

This product will be manufactured at Lupin’s Nagpur facility in India.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD ) had estimated annual sales of USD
1 million in the U.S. (IQVIA MAT March 2023).

Read also: Lupin bags USFDA nod for generic equivalent of Nascobal Nasal Spray

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The
Company develops and commercializes a wide range of branded and generic formulations, biotechnology
products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin
America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has
a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s
health areas. The company
invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has
been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.Read also: Lupin receives over Rs 205 crore from AbbVie for meeting key product development milestone

The product is a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical, Inc. This product will be manufactured at Lupin’s Somerset facility in the US.

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023).

Cyanocobalamin is a form of vitamin B12 used for the treatment of deficiency of vitamin B12.

Read also: Lupin CSR arm, Maharashtra Govt collaborate to address growing prevalence of cardiovascular diseases, COPD

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin gets USD 25 million from AbbVie for novel MALT1 inhibitor program to treat hematological cancers