Novartis, Teva, Eli Lilly, and Adamis Led Drug Approval News

A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news from Novartis, Teva, Eli Lilly and Company as well as Adamis Pharmaceuticals.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 14, 2017 to Tuesday June 20, 2017.

European Commission Approves Novartis’ Biosimilar of Roche’s MabThera
The European Commission (EC) has approved from Sandoz, the generics arm of Novartis, Rixathon, a biosimilar referencing Roche’s MabThera, a drug to treat cancer and autoimmune diseases, in all indications. MabThera/Rituxan is Roche’s top-selling drug with 2016 sales of CHF 7.3 billion ($7.48 billion).

Rixathon was approved to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia as well as immunological diseases, such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Sandoz  has four biosimilar medicines approved in Europe and plans to obtain approval for and launch four more biosimilars of major oncology and immunology biologics by 2020.

This is the second biosimilar approval for MabThera in 2017. In February 2017, Celltrion Healthcare, the marketing, sales, and distribution arm of Celltrion, an Incheon, South Korea-based pharmaceutical company, also received approval from the EC for Truxima (rituximab), another biosimilar to Roche’s MabThera/Rituxan.

Source: Novartis

FDA OKs Adamis’ Competitor to Mylan’s EpiPen
Adamis Pharmaceuticals, a San Diego-based a specialty biopharmaceutical company, has received US Food and Drug Administration approval for Adamis’ epinephrine injection 1:1000 (0.3-mg prefilled single-dose (PFS) syringe) for the emergency treatment of allergic reactions (Type I), including anaphylaxis. The FDA has also approved the PFS trade name of Symjepi.

Symjepi provides two single-dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods (such as nuts), drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis.

The company is in the process of exploring commercialization options and said it is in discussions with potential partners. In the interim, the company expect to build inventory levels in preparation for an anticipated launch in the second half of this year.

The product will compete with Mylan’s EpiPen, an auto-injector-based epinephrine product, which came under Congressional attention in 2016 with regard to the pricing of the product.

Source: Adamis Pharmaceuticals

Teva Launches Generic of Merck & Co.’s Anti-Cholesterol Drug Zeita
Teva Pharmaceutical Industries has announced the launch of a generic of Merck & Co. Inc.’s anti-cholesterol drug, Zetia (ezetimibe), in 10-mg tablets in the US.

Ezetimibe is used to lower levels of total cholesterol and low-density lipoprotein cholesterol in the blood for patients who cannot control their cholesterol levels by diet and exercise alone. The drug works to reduce the amount of cholesterol the body absorbs.

Ezetimibe had annual sales of approximately $2.7 billion in the US, according to QuintilesIMS data as of March 2017 and as reported by Teva.

Source: Teva Pharmaceutical Industries

FDA Approves Eli Lilly’s Prefilled Syringe for Humalog in Smaller Doses
The US Food and Drug Administration has approved Eli Lilly’s Humalog (insulin lispro) Junior KwikPen, a prefilled pen with half-unit dosing capability, for treating diabetes to enable finer dose adjustment for those who need it.

The Humalog Junior KwikPen will be available in US pharmacies later this year. Lilly also has a pending application for the KwikPen regulatory approval in the European Union.

Source: Eli Lilly and Company

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