The latest set of opinions from the European Medicines Agency includes recommendations for a GlaxoSmithKline meningitis vaccine, backing for expanded use of Abbott’s blockbuster Humira and support for lifting the suspension on Bayer’s blood loss agent Trasylol.
First up, the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of GSK‘s Nimenrix for immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y. The company had submitted data from 17 clinical trials in more than 8,000 patients aged one and above.
There was also backing for a conditional approval for Cell Therapeutics‘ Pixuvri (pixantrone) for adult patients with multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. At the end of last month, the company pulled its New Drug Application in the USA saying it needed additional time to prepare for the review of the drug by the Food and Drug Administration’s Oncologic Drugs Advisory Committee, scheduled for February 9.
Meantime, Scotland’s ProStrakan, a subsidiary of Japan’s Kyowa Hakko Kirin, was boosted by a positive opinion on Sancuso (granisetron), a transdermal patch for the prevention of chemotherapy-induced nausea and vomiting. The CHMP has also recommended, for use outside the European Union, Pyramax, a fixed combination consisting of pyronaridine and artesunate, an artemisinin derivative, from Shin Poong Pharmaceutical Co for malaria. On occasion, the agency gives external scientific opinions, in cooperation with the World Health Organisation.
The CHMP has also issued a positive opinion to expand the label on Abbott‘s Humira (adalimumab) to include the treatment of adults with moderate to severely active ulcerative colitis for whom conventional therapies are not suitable. If the European Commission acts on the advice, Humira will be the first self-injectable biologic therapy available for those UC patients.
Also, Amylin and soon-to-be ex-partner Eli Lilly got a potential a new approval for the diabetes drug Byetta (exenatide) for use in combination with basal insulin with or without other common diabetes drugs in patients who have not been able to get their blood sugar under control with the other treatments.
Warnings for Novartis’ aliskiren
Meantime, the EMA has completed a safety review of Novartis’ blood pressure drug Rasilez (aliskiren) and demanded label changes, after a clinical trial was halted at the end of 2011 over concerns it was linked to an increased risk of stroke and kidney problems in certain patients. The agency has ruled that the treatment, once touted as a successor to the blockbuster Diovan (valsartan) should be contraindicated in patients with diabetes or moderate to severe renal impairment who take angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
In addition, the agency recommended the inclusion of a warning that the combination of aliskiren and ACE inhibitor or ARBs is not recommended in all other patients because adverse outcomes cannot be excluded. In December, Novartis stopped promotion of the drug and combination products containing aliskiren in combination with an ACE inhibitor or an ARB.
Bayer’s Trasylol to return to market?
A key highlight from the CHMP meeting included a recommendation that the suspension of the marketing authorisations for Bayer’s Trasylol (aprotinin) be lifted.
The drug was yanked from the global market by the German group in November 2007, after a Canadian study from the Ottawa Health Research Institute, called BART, was stopped after it seemed that Trasylol posed a higher risk of death compared to two antifibrinolytic drugs – epsilon-aminocaproic acid and tranexamic acid – used in the trial.
However, the committee found that there were a number of problems with the way the BART study was conducted, “which cast doubt on the previous conclusions”. These included the imbalances in the way blood-thinning medicines such as heparin were used, inappropriate monitoring of the use of these medicines and how problems with the way that data from some patients were excluded from the initial analysis.
As such, the CHMP says the benefits of Trasylol, which is the subject of a stack of lawsuits in the USA, in preventing blood loss outweigh its risks in patients undergoing isolated heart bypass surgery.
