The latest set of opinions from the European Medicines Agency has been dominated by the news that a safety review of the benefits and risks of Novartis' oral multiple sclerosis treatment Gilenya has begun.
The agency's Committee for Medicinal Products for Human Use (CHMP) has started the probe following reports of heart problems in patients taking Gilenya (fingolimod), as well as the death of one patient in the USA less than 24 hours after the first dose. The exact cause of death is still unexplained, the agency notes.
The EMA also cited six other unexplained deaths (including three cases of sudden death) that have been after starting treatment with Gilenya, plus three deaths due to heart attack and one due to disruption of the heart rhythm. Currently, "it is not clear if these were caused by Gilenya or not", it stressed.
Staying with MS, the EMA released a guideline on how drugmakers should test biosimilars containing interferon beta for public consultation until the end of May. It covers the "non-clinical and clinical requirements" for firms looking to make versions of drugs such as Bayer's Betaferon/Betaseron, Merck KGaA's Rebif and Biogen Idec's Avonex.
Better news for Novartis came with a recommendation from the CHMP to back approval of the firm's Signifor (pasireotide) for the treatment of Cushing’s disease, a very rare life-threatening disease where a small tumour of the pituitary makes too much of the hormone adrenocorticotrophin. Cushing’s disease affects around 20,000 people in the European Union.
Allos lymphoma drug rejected
However the committee issued a negative opinion on Allos Therapeutics' Folotyn (pralatrexate) for patients with relapsed or refractory peripheral T-cell lymphoma, saying it was concerned that the main study was designed in a way that did not allow it to assess the benefit of the medicine, particularly since Folotyn was not compared with any other treatment or placebo.
The CHMP said there was no clear improvement seen in the condition of the patients, as the study looked at the patients’ response to treatment but did not allow an assessment of the drug's effect on overall or progression-free survival. Allos disagrees and will submit a request for re-examination.
Other highlights of the meeting saw the EMA recommended the suspension of meprobamate-containing medicines used to treat a variety of conditions, including anxiety states, alcohol withdrawal, migraine attacks and insomnia. The CHMP noted that there was a risk of serious and potentially fatal side effects, such as coma, linked to such drugs, sold in a number of countries as Equanil.
The EMA has also backed expanded approvals for Merck & Co/Johnson & Johnson's Remicade (infliximab) to include the treatment of paediatric ulcerative colitis, and for Sanofi's RotaTeq vaccine.