European regulators have issued their latest round of recommendations which include good news concerning the new triple-therapy HIV drug Atripla but a setback for Switzerland’s Actelion and its Gaucher disease drug Zavesca.
The latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted seven positive opinions, including two for biosimilars and one for a straight generic. Most notable of the recommendations was the one given to Atripla, which combines Bristol-Myers Squibb’s Sustiva (efavirenz) and Gilead's Emtriva (emtricitabine) and Viread (tenofovir) and will be sold, if approved, through a three-way joint venture set up with Merck & Co. The drug, which was approved in the USA in July, is a once-daily, triple therapy for HIV-1 that is delivered in a single tablet.
There was also good news for GlaxoSmithKline which received a positive opinion on Avamys (fluticasone furoate) for the treatment of the symptoms of allergic rhinitis and the CHMP also recommended Abraxis BioScience's breast cancer drug Abraxane (albumen-bound paclitaxel) and Alcon’s Nevanac (nepafenac), for postoperative pain and inflammation associated with cataract surgery.
The EMEA’s advisors also adopted positive opinions for two biosimilar epoetin products from Stada Arzneimittel and Hospira, their anaemia drugs which will be called Silapo and Retacrit, respectively, while a recommendation for Teva’s copy of Eli Lilly’s schizophrenia drug Zyprexa (olanzapine) was also given.
The news was worse for Actelion, however, as the CHMP adopted a negative opinion for an extension of the indication of the firm’s Gaucher disease drug Zavesca (miglustat) to cover the treatment of Niemann-Pick type C disease, an inherited neurodegenerative disease affecting children and adolescents. The Swiss firm said it plans to make a fresh application.
Recommendations by the CHMP are normally endorsed by the European Commission within a couple of months.