Among the highlights of the European Medicines Agency's latest monthly meeting, the positive benefit-risk balance of Servier's osteoporosis drug Protelos has been confirmed but new warnings have been issued.
After a review of a study in France which identified 199 severe adverse reactions reported with Protelos (strontium ranelate) from January 2006 to March 2009, half of which were venous thromboembolism events and a quarter related to skin reactions, the agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the drug "remains an important treatment for women with osteoporosis". However, it adds that "changes to the prescribing advice are necessary to better manage associated risks".
The CHMP has therefore advised that doctors should not prescribe Protelos to patients with current, or a history of, VTE, as well as patients who are temporarily or permanently immobilised. It adds that when treating patients over 80 at risk of VTE, doctors should re-evaluate the need to continue treatment with the drug.
The agency has also warned patients to stop treatment immediately when symptoms of severe allergic reactions, including skin rash, occur. It adds that "treatment should not be re-started at any time in these patients".
Other highlights of the meeting included positive opinions on Accord Healthcare and Fresenius' generic versions of Sanofi's chemotherapy Taxotere (docetaxel) and Teva's copies of Novartis' bone drug Zometa (zoledronic acid).
The EMA has also recommended that manufacturing of the anticancer medicines Johnson & Johnson's Doxil/Caelyx (doxorubicin) and Epicept's Ceplene (histamine) be transferred from the troubled Ben Venue Laboratories site in Bedford, Ohio, USA to alternative facilities. The latter is a contract manufacturing subsidiary of Boehringer Ingelheim, and last month the agency removed the Bedford facility as an approved location for the manufacture of a dozen products, including Pfizer's cancer drug Torisel (temsirolimus), Takeda's Velcade (bortezomib) for multiple myeloma, Astellas' antibiotic Vibativ (telavancin) and Celgene's leukaemia/lymphoma treatment Vidaza (azacitidine).
The CHMP has also delayed releasing the findings of its safety review of Novartis's multiple sclerosis pill Gilenya (fingolimod) until April 20.
A probe was begun in January to assess Gilenya's benefits and risks, following reports of heart problems in patients and the death of a patient in the USA within 24 hours of taking the first dose of the drug.