Amgen boosted in race to market for migraine drug
pharmafile | November 17, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Amgen, Novartis, erenumab, migraine, phase III
Amgen released positive results from their second Phase III trial for experimental migraine drug, known as erenumab, which it is co-developing alongside Novartis. The study held 955 participants who suffered from ‘episodic’ migraines, meaning that they suffer from migraines up to 14 days every month.
The results showed the drug reduced the number of days with migraines across all doses against the placebo. The figures, broken down by dosage, saw patients on the low dosage have migraines reduced by 3.2 days per month while those on high dosage saw a decline of 3.7 days; this was a favourable reaction compared with the placebo that saw a 1.8 day reduction. The patients enrolled in the study suffered from migraines on average 8.3 days per month and, therefore, at high dosage, patients saw migraine days reduced by almost half.
The method of treatment involved an injectable drug being administered once every month for six months. This is a step up from their previous Phase III trials that saw patients given doses for only three months. The treatment saw a safety profile that was comparable to the placebo.
“Migraine is ranked one of the most debilitating diseases by the World Health Organization, yet it is often under-diagnosed and under-treated. People who experience migraine battle the disease for many years and it has significant impact on their everyday activities,” said Sean E. Harper, executive vice president of Research and Development at Amgen. “The results of this study are important because they confirm the results from our previous studies and add to our body of research in episodic migraine. We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians.”
Amgen is expected to begin filling with regulatory agencies in 2017, putting it at a significant advantage against other developers of drugs that work by blocking calcitonin gene-related peptide. Rival companies Alder, Eli Lilly and Teva are also working on similar drugs, with Phase III results expected to begin through in 2017.
However, these positive results from Amgen could see them jump to the front of the pack in getting their own drug onto the market. As the drug is being co-developed by Novartis, as part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and rest of world.
Ben Hargreaves
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