EU panel backs Merck’s Brinavess and Sycrest, probes ARB/cancer link

Merck & Co, Pharming and Shire are among the chief beneficiaries of the latest recommendations issued by the advisors to the European Medicines Agency, while Basilea’s superbug drug ceftobiprole has again been rejected.

First up, the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Merck’s Brinavess (vernakalant) as a treatment for atrial fibrillation. The drug, licensed from Cardiome Pharma Corp, will be “the first product in a new class of pharmacologic agents for cardioversion of AF” to launch in the European Union, Merck noted.

The CHMP also recommended that Sycrest (asenapine) be approved as a treatment for treating moderate to severe manic episodes associated with bipolar disorder in adults but did not back the drug as a treatment for schizophrenia. The compound is approved for both indications in the USA, where it is marketed as Saphris.

The EMA advisors issued a positive opinion on Ruconest (conestat alfa), previously known as Rhucin, from Pharming Group for the treatment of angioedema attacks. The drug, which is derived from the milk of rabbits, was rejected by the regulator over two years ago, but the Dutch biotechnology group conducted further trials and the news sent shares up 12.5%.

Shire was also celebrating the support of the CHMP for Vpriv (velaglucerase alfa) for the treatment of Gaucher disease following an accelerated assessment “due to a major public health interest”. The drug will be an alternative to Genzyme Corp’s Cerezyme (imiglucerase) which has been plagued with manufacturing problems.

The Committee also confirmed its previous rejection and adopted a final negative opinion on Basilea’s antibiotic Zeftera (ceftobiprole) for the treatment of complicated skin and soft-tissue infections. The CHMP issued a negative opinion in February stating that inspections had shown that Phase III studies run by the Swiss firm’s then-partner Johnson & Johnson had not been conducted in compliance with good clinical practice in some sites.

CHMP investigates ARB/cancer link
Meantime, the CHMP has begun looking at the possible risk of cancer in patients taking angiotensin II receptor inhibitors for blood pressure. This follows the publication of a meta-analysis reviewing nine trials involving almost 95,000 patients, which suggests that ARBs may be linked with “a modestly increased risk of new diagnoses of cancer when compared with placebo or other heart medicines”.

The vast majority of patients in the meta-analysis, published earlier this month in The Lancet received Boehringer Ingelheim and Astellas' Mycardis (telmisartan), though the German firm has said it disagrees with the findings.