Lilly and Mylan Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Lilly, Mylan, as well as Flexion Therapeutics.

Editor’s Note: Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, October 4, 2017 to Tuesday, October 10, 2017.

FDA OKs Lilly’s NME Breast Cancer Drug
The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s new molecular entity, Verzenio (abemaciclib), in combination with fulvestrant, for treating women with breast cancer.

Lilly’s combination was approved for treating women with hormone receptor-positive (HR+),  human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with disease progression following endocrine therapy and as a monotherapy for treating adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

Verzenio is a cyclin-dependent kinase 4 and 6 inhibitor that will be available as 50-, 100-, 150- and 200- mg tablets. The recommended dose of Verzenio, in combination with fulvestrant, is 150 mg orally twice daily. As a monotherapy, the recommended dose of Verzenio is 200 mg orally twice daily. Both doses are recommended to be continued until disease progression or unacceptable toxicity occurs.

Verzenio will be available in the US by mid-October 2017.

Source: Eli Lilly and Company

Mylan’s Partner Gets EU OK for Generic of Teva’s Copaxone
Synthon, a Nijmegen, the Netherlands-based pharmaceutical and generic-drug company has received approval in Europe for glatiramer acetate injection 40 mg/mL, a generic version of Teva Pharmaceutical Industries’ top-selling drug, Copaxone 40 mg/mL (glatiramer acetate), for treating patients with relapsing forms of multiple sclerosis (MS). Copaxone had 2016 global revenues of $4.2 billion.

Mylan is partnered with Synthon, the developer and supplier of its European glatiramer acetate injection 20 mg/mL and 40 mg/mL products, and has exclusive distribution and supply rights for the products for Germany, France, Spain, Portugal, Belgium, Italy, the Netherlands, the UK, the Republic of Ireland, Switzerland, Greece, Denmark, Sweden, Norway, Finland, Cyprus and Malta.

The approval in Europe follows the US Food and Drug Administration’s (FDA’s) recent approval of Mylan’s two dosings of glatiramer acetate injection (20-mg/mL and 40-mg/mL). The approval of the 40 mg/mL formulation is significant. Teva had successfully applied a generic defense strategy for Copaxone when it launched a 40-mg/mL formulation of the product with a three-times a week dosing regime following the patent expiration of a first-generation 20-mg/mL formulation with more frequent dosing. Patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched by Teva in the US in January 2014 and was approved in Europe in December 2015.

Teva’s business strategy for Copaxone relies heavily on the continued migration of a substantial percentage of Copaxone patients using daily doses (the 20-mg/mL formulation) to the 40- mg/mL, three-times-a-week version.

The European approval follows the 2016 approval of glatiramer acetate injection 20 mg/mL, which already is available in several European markets.

A grant of national marketing authorizations is expected to follow in the near future, according to Mylan.

Source: Mylan and Synthon

Flexion Gets Approval for Non-Opioid Drug for Osteoarthritis Knee Pain
The US Food and Drug Administration (FDA) has approved Flexion Therapeutics’ Zilretta (triamcinolone acetonide extended-release injectable suspension), an intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that uses Flexion’s proprietary microsphere technology. 

Flexion expects Zilretta will be available in the US by the end of October 2017.

Source: Flexion Therapeutics

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