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Boehringer/Lilly's empagliflozin among CHMP recommendations

If approved it will be marketed as Jardiance

Lilly Boehringer IngelheimBoehringer Ingelheim and Eli Lilly's new diabetes drug Jardiance was among nine new pharma products recommended for approval by the European Medicines Agency (EMA) late last week.

In the latest round of opinions, the Committee for Medicinal Products for Human Use (CHMP) gave its backing to Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

Empagliflozin is an SGLT2 inhibitor and - after full approval by the EMA - will compete in the EU market with AstraZeneca's Forxiga (dapagliflozin) and Johnson & Johnson's Invokana (canagliflozin).

Its approval in the US was delayed by the FDA earlier this month after the agency raised concerns about deficiencies at the plant which manufactures the drug.

The CHMP also gave the nod to Takeda's locally-targeted drug for ulcerative colitis and Crohn's disease - Entyvio (vedolizumab).

It was backed for use in patients who cannot tolerate or respond poorly to tumour necrosis factor (TNF) antagonists such as J&J's Remicade (infliximab). The drug is billed as a potentially safer alternative to TNF blockers as it only exerts its anti-inflammatory in the gastrointestinal tract.

Vedolizumab's regulatory review in the US has been delayed by a few months, but has been backed by an FDA advisory committee and the FDA is due to deliver a verdict on May 20.

The CHMP also recommended approval of Olysio (simeprevir) for the treatment of chronic hepatitis C in adults in combination with other medicinal products. The protease inhibitor was first approved in the US last November for use alongside pegylated interferon and ribavirin and is competing in the fast-evolving hepatitis C marketplace with the likes of Gilead Sciences' Sovaldi (sofosbuvir).

Other positive opinions issued by the CHMP included Actavis' Ebilfumin, a generic version of Roche's flu drug Tamiflu (oseltamivir), and GlaxoSmithKline's Revinty Ellipta (fluticasone furoate and vilanterol) for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

There were also recommendations for four orphan drugs: Janssen-Cilag's Sylvant (situximab) and, along with the companion diagnostic drugs Folcepri (etarfolatide) and Neocepri (folic acid), Endocyte's Vynfinit (vintafolide).

Article by
Phil Taylor

24th March 2014

From: Sales, Regulatory



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