Boehringer Ingelheim, GlaxoSmithKline and Teva Pharmaceutical Industries are among the chief beneficiaries of the latest recommendations issued by advisors to the European Medicines Agency.

First up, the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on Boehringer’s antihypertensive Twynsta, which combines the company’s Micardis (telmisartan) with Pfizer’s Norvasc (amlodipine). The combo was approved in the USA last October,

The CHMP has also backed the extension on the indication on GSK’s bloodthinner Arixtra (fondaparinux) to include treatment of acute symptomatic spontaneous superficial vein thrombosis (SVT) of the lower limbs without concomitant deep vein thrombosis. There was also a thumbs-up for Gilead Science’s antiviral Viread (tenofovir) to include treatment of chronic hepatitis B in adults with decompensated liver disease, while Pfizer’s Xalatan (latanoporost) eye drops have been granted a positive opinion in the treatment of paediatric patients with elevated intraocular pressure and paediatric glaucoma.

The agency’s advisors also recommended the green light for Teva’s generic versions of Sanofi-Aventis’ blockbuster bloodthinner Plavix (clopidogrel) and backed a copycat version of Roche’s Cellcept (mycophenolate mofetil), to be called Myclausen from Germany’s Herbert J Passauer for the prophylaxis of acute transplant rejection in combination with ciclosporin and corticosteroids.

Restrictions on Cephalon’s Provigil
The CHMP has also completed a review of Cephalon’s sleep drug Provigil (modafinil) and recommended restricting its use to the treatment of sleepiness associated with narcolepsy. The review had been initiated because of a number of safety concerns relating to neuropsychiatric disorders, skin and subcutaneous tissue reactions”as well as significant off-label use and potential for abuse”.

As a result, the committee says that Provigil should not be prescribed for the treatment of idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea or chronic shift work sleep disorder.

Finally, the CHMP has finalised a review of topical formulations of ketoprofen, a non-steroidal anti-inflammatory drug, and concluded that the benefits of these medicines continue to outweigh their risks.