AbbVie, Gilead, Novartis, and Sanofi Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, Gilead, Novartis, Novo Nordisk, and Sanofi.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 9, 2016 to Tuesday November 15, 2016.

CHMP Positive on AbbVie’s Humira to Treat Skin Disease
AbbVie has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for its anti-inflammatory biologic, Humira (adalimumab), to treat active moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The indication that AbbVie is specifically seeking is the use of Humira in treating HS in adolescents 12 years of age and older with an inadequate response to conventional systemic HS therapy. Humira was approved for adults with moderate-to-severe HS by the European Commission in July 2015. Humira is AbbVie’s top-selling product with global net sales of $14 billion in 2015.

In the European Union (EU), Humira is indicated for use in adults with moderate-to-severe active and progressive rheumatoid arthritis (RA), severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, active moderate-to-severe hidradenitis suppurativa, and non-infectious intermediate, posterior and panuveitis in adults. The biologic is also approved in the EU for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn’s disease, and active polyarticular juvenile idiopathic arthritis (JIA).

In the US, Humira is indicated for moderately to severely active RA, moderately to severely active polyarticular JIA in patients 2 years of age and older, active psoriatic arthritis, active AS, moderately to severely active Crohn’s disease with an inadequate response to conventional therapy, moderately to severely active Crohn’s disease where there is an inadequate response to corticosteroids or immunomodulators in patients six year of age and older, moderately to severely active Crohn’s disease where there is an inadequate response to corticosteroids or immunomodulators, moderate-to-severe chronic plaque psoriasis, moderate-to-severe HS, and non-infectious intermediate, posterior and panuveitis in adults.

Source: AbbVie


EMA Recommends Nine Drugs for Approval
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended nine medicines for approval, including three biosimilars, at its November 2016 meeting.

The CHMP recommended granting a marketing authorization for CSL Behring’s Afstyla (lonoctocog alfa) for preventing and treating bleeding in patients with hemophilia A.

Gilead Sciences received a positive opinion from the CHMP on the company’s marketing authorization application for Vemlidy (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for treating chronic hepatitis B virus (HBV) infection in adults and adolescents 12 years and older who weigh 35 kilograms or more. The data included in the application support the use of the drug in treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection. 

In related news, Vemlidy was approved by the US Food and Drug Administration (FDA) for treating adults with chronic HBV infection with compensated liver disease.

Novo Nordisk has received a positive opinion from the CHMP recommending the use of Fiasp (fast-acting insulin aspart) in treating adults with Type 1 and Type 2 diabetes. The CHMP recommends Fiasp to be indicated for use as the bolus component of basal-bolus therapy in combination with basal insulin and for continuous subcutaneous insulin infusion via an insulin pump. Novo Nordisk has developed Fiasp as mealtime insulin. The company expects to receive final marketing authorization from the European Commission (EC) in the first quarter of 2017.

Sanofi  has received a positive opinion from the CHMP on Suliqua, a once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide being developed for diabetes treatment. The CHMP recommended the use of Suliqua in combination with metformin for the treatment of adults with Type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

Suliqua is the brand name in Europe for this combo drug, and the EC is expected to make a final decision on marketing authorization for it in the coming months. The fixed-ratio combination is currently under review in a total of nine markets, including the US, where an FDA decision is anticipated later this month.

The committee also recommended the approval of three biosimilars: Merck & Co.’s Lusduna (insulin glargine) for treating diabetes, and STADA Arzneimittel’s Movymia (teriparatide), and Gedeon Richter’s Terrosa (teriparatide), both for treating osteoporosis.

In addition, the CHMP recommended two of Mylan’s generic products for approval: Darunavir Mylan (darunavir) for treating human immunodeficiency virus infection and Tadalafil Generics (tadalafil) for treating pulmonary arterial hypertension.

Source: European Medicines Agency


Novartis Gets Priority Review for Cancer Drug
Novartis has received priority review from the US Food and Drug Administration (FDA) for its new drug application for midostaurin, the company’s investigational anti-cancer drug candidate for treating acute myeloid leukemia (AML). More specifically, midostaurin is an oral, multi-targeted kinase inhibitor that Novartis is developing to treat AML in newly diagnosed adults with an FMS-like tyrosine kinase-3 mutation. The company is also developing the drug to treat advanced systemic mastocytosis. Outside the US, the marketing authorization application for midostaurin in these indications has been accepted by the European Medicines Agency.

Source: Novartis


Novo Nordisk Submits Insulin-Label Update in EU…
Novo Nordisk has submitted an application to the European Medicines Agency for including data from the two Phase IIIb trials in the label for Tresiba (insulin degludec), a once-daily basal insulin that provides a duration of action beyond 42 hours in the treatment of Type 1 and Type 2 diabetes.

Tresiba received its first regulatory approval in September 2012 and has since been approved in more than 70 countries globally. It was approved by the US Food and Drug Administration in September 2015.

Source: Novo Nordisk

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