The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use include good news for Regeneron and Novartis, while Nycomed’s cancer pain drug Instanyl has been approved.
First up, the EMEA has granted marketing authorisation for Instanyl (fentanyl), a first-in-class nasal spray, for breakthrough pain in cancer patients who receive chronic opioid treatment for the management of their background pain. The approval is based on Phase III data which has shown clinically significant relief at ten minutes after administration in 58% of Instanyl-treated pain episodes, while all doses were well tolerated during a ten-month follow-up period.
The Zurich-headquartered company quoted Stein Kaasa from Trondheim University Hospital in Norway as saying that the “rapid uptake via the nose translates into fast onset of action helping patients to be in control of their pain”. He added that further data has demonstrated an onset of pain reduction as early as five minutes “underlining the clinical benefit this treatment represents”.
Meantime, the CHMP has recommended approval of Regeneron’s Arcalyst (rilonacept) as a treatment for cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells Syndrome. CAPS is a rare, genetic condition causing recurrent fever, rash and joint pain.
There were positive recommendations for Novartis’ CAPS drug Ilaris (canakinumab) and its hypertension combo Exforge HCT (amlodipine/valsartan/hydrochlorothiazide). The Committee also backed Resolor (prucalopride), from Belgium’s Movetis for the treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
The CHMP adopted a negative opinion for Gemesis (bercaplermin), from Biomimetic Therapeutics intended for the treatment of periodontally related defects and Pierre Fabre’s milnacipran for fibromyalgia. The committee also confirmed that the approval on Pfizer’s epilepsy drug Lyrica (pregabalin) should not be extended to cover fibromylagia.
However, it has recommended extensions of indication for Merck Sharp & Dohme’s HIV drug Isentress (raltegravir), UCB’s epilepsy treatment Keppra (levetiracetam) and Roche’s Mabthera (rituximab), while Wyeth’s advanced renal cell carcinoma drug Torisel (temsirolimus) has been recommended as a treatment for patients with relapsed and/or refractory mantle cell lymphoma.
H1N1 vaccines fast-tracked
The EMEA also noted that it has started to receive data on H1N1 pandemic vaccines and will fast-track the review of data as vaccine manufacturers make them available.
Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the bird glu H5N1 virus strain, “which is similar to H1N1”, the CHMP notes. These vaccines were developed “in the knowledge that the virus strain would be changed in the event of a declared pandemic, to include the strain causing the pandemic”, it adds.
In addition to the mock-up vaccines, a number of other pandemic influenza vaccines are currently under development, and preliminary data from GSK and Sanofi Pasteur are also being assessed “on an accelerated basis”. The EMEA says that “rare adverse reactions can only be detected during the wider use of the vaccine” but regulators and drugmakers will “implement plans to actively investigate and monitor the safety of these vaccines and take swift action if safety issues emerge”.
By Kevin Grogan
July 27, 2009