The latest set of opinions from advisors to the European Medicines Agency has seen three innovative medicines recommended for approval, but rejections for Teva’s multiple sclerosis pill and Novartis’ new heart failure drug.
First up, the agency’s Committee for Human Medicinal Products (CHMP) has issued a positive recommendation on Bayer’s pulmonary hypertension drug Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. It has also backed Takeda’s Latuda (lurasidone), licensed from Dainippon Sumitomo Pharma, for schizophrenia and GlaxoSmithKline’s diabetes drug Eperzan (albiglutide; see link).
In addition, the CHMP issued a positive opinion on Finox Biotech’s Bemfola, a biosimilar of Merck Serono’s Gonal-f (follitropin alfa) for infertility and backed two generics of Novartis drugs – 3M Health Care’s version of the Alzheimer’s treatment Exelon (rivastigmine) and Teva’s copy of Zometa (zoledronic acid) for osteoporosis and Paget’s disease of the bone.
The CHMP also recommended the approval of Linepharma France’s Hemoprostol (misoprostol) for the treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available. Hemoprostol will be intended exclusively for outside the European Union.
Faring less well was Teva and Active Biotech’s multiple sclerosis pill Nerventra (laquinimod). The CHMP adopted a negative opinion, saying the risk-benefit profile of the drug is not favourable at this time and the companies intend to request a re-examination.
Novartis to seek conditional OK for serelaxin
Novartis is also asking for a fresh review of Reasanz (serelaxin) which has not been recommended for the treatment of acute heart failure. The CHMP said that results from the one main study filed did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours, and although some benefit was shown over five days, “it was not clear how this was of clinical relevance”.
Furthermore, the Committee had concerns about the way the effectiveness of the medicine in the study had been analysed, saying further studies would be needed. David Epstein, head of Novartis Pharmaceuticals, said: “It has become apparent through the review process and in accordance with advice we’ve received that the current evidence package may be more compatible with an application for conditional approval in the EU”.
The CHMP also issued negative opinions for two orphan medicines, AB Science’s Masiviera (masitinib) for certain types of advanced pancreatic cancer and Translarna (ataluren) from PTC Therapeutics for Duchenne muscular dystrophy.
Other highlights from the CHMP meeting included expanding the indications on Novo Nordisk’s NovoThirteen (catridecacog) and Johnson & Johnson’s Stelara (ustekinumab). There was also backing for Novartis’ asthma drug Xolair (omalizumab) to be used as a treatment for chronic spontaneous urticaria, a severe form of hives.
