Novartis/Amgen migraine jab works in tough-to-treat patients
Novartis continues to build the case for its Aimovig migraine injection,with data showing it works in a tough-to-treat patient group.
Aimovig (erenumab), developed in partnership with Amgen, is one of a clutch of drugs from the calcitonin gene-related peptide (CGRP) class drugs that are closing in on approval.
The drug has already been filed with the FDA, and a regulatory decision is expected in the coming weeks.
Novartis and Amgen are ahead in the race to get a CGRP drug approved, as rivals Teva, Eli Lilly, and Alder have yet to file their drugs with the FDA.
The Swiss pharma company has already produced data that it hopes will support a licence in patients with episodic and chronic disease, for patients experiencing four or more days of migraine per month.
Now data from the phase 3b LIBERTY trial shows that Aimovig can be used as a preventive treatment option for patients who had previously failed two to four other treatments due to lack of efficacy or intolerable side effects.
The study is the first to test a CGRP drug in this difficult patient population, involving 246 patients who had previously experienced two to four treatment failures.
They randomly received either monthly subcutaneous injections of either Aimovig 140mg, or placebo for 12 weeks.
Results unveiled at the American Academy of Neurology in Los Angeles showed patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by at least 50%, with more than twice as many patients the drug achieving this reduction compared with placebo.
Results showed that 30.3% of patients on Aimovig achieved this primary goal, compared with 13.7% in a placebo group.
Patients in the Aimovig group also experienced statistically significant and clinically meaningful improvements in secondary goals including reduction in monthly migraine days, decrease in use of migraine drugs, 75% and 100% reduction in monthly migraine days, and improved physical function.
If approved, Novartis and Amgen will co-market Aimovig in the US. Amgen has exclusive marketing rights in Japan, while Novartis has exclusive rights in the rest of the world.
The drug will be administered every month using a self-injection device if it gets the go-ahead from the FDA.
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