Thursday, June, 13, 2024 09:59:02

The FDA has approved a migraine treatment developed by drug giant Eli Lilly, which is the first of a new class of medications, confirmed sources familiar with the matter. The new drug is called Emgality and is aimed at changing the way a medical condition, which reportedly affects nearly 38 million Americans, is treated.

Emgality is a monthly injection and has a list price of $575 per month or $6,000 per year, the sources further informed. Reports for two phase 3 trials of Emgality show that Eli Lilly discovered patients on the medication had between 3.6 and 4-day reduction in migraine days per month, and only those patients were selected for the trial who had exhibited between 4 to 14 migraine days per month.

The results were better than the 2.15 and 1.85 days reduction that was observed in the placebo groups. The company also reported 100% migraine reductions in 11.5% of Emgality patients, compared to 5.7% of those who were given placebo and showed a 100% reduction.

Records indicate that no drugs were available in the market until May which had been originally approved for reducing migraines. But only in the last few months, FDA had approved three preventive medications that target CGRP (calcitonin gene-related peptide), a peptide known to play a vital role in migraines, and Emgality is the latest of these drugs.

Ajovy developed by Teva and Aimovig made by Amgen and Novartis are the other medications similar to Emgality, and also are listed at $575 for a monthly dose or about $6,900 per year. Some experts have pegged Aimovig to record $1 billion in sales by 2022 and Amgen has been handing out free samples of two months’ worth of treatment.

Wei-Li Shao, Lilly’s vice president of neuroscience business, has stated that the company is planning to give starter kits of Emgality to the offices of doctors who treat migraines. Lilly is also considering having a patient access program to offer up to 12 months of free Emgality.