Racing after the leaders, Eli Lilly's migraine drug clears another pivotal study
A month after securing approval for cluster headaches, Lilly’s $LLY migraine drug Emgality has scored in a late-stage trial as a preventive treatment for chronic and episodic migraines in patients who have failed more than two standard-of-care prophylactic treatments.
Emgality was the last injectable to win approval for migraine prevention last September, months after Aimovig from Amgen $AMGN and Novartis $NVS, and Teva’s $TEVA Ajovy. Each has demonstrated a reduction in migraine frequency in about half of patients when tested in clinical studies and is priced at $6,900 a year, or $575 per month. Tiny Alder’s $ALDR CGRP drug is under FDA review.
Emgality was tested against a placebo in a 462-patient study called CONQUER. At baseline, patients had on average 13.2 monthly migraine headache days. Treatment with Emgality reduced monthly migraine headache days by 4.1 days (p<0.0001) compared with 1 day with placebo.
According to the Migraine Research Foundation, migraines are the third most prevalent illness in the world, affecting about 39 million in the United States and some 1 billion worldwide. The market for migraine drugs is expected to hit $8.7 billion by 2026, according to Globaldata. Before the slate of approvals this year, patients were largely treated with a host of drugs including antidepressants, hypertension medicines and a class of drugs called triptans.
Among users of preventive migraine medications, more than 40% have a history of previous preventive medication failure or of switching treatments, Lilly noted on Monday.
This new class of biologics, known as CGRP (calcitonin gene-related peptide) inhibitors, target the CGRP protein that transmits pain signals into the brain and is believed to be instrumental in generating and maintaining headaches associated with migraines.
Emgality generated lower-than-expected second-quarter sales of $34.3 million, while Aimovig raked in generally in-line sales of $83 million. Teva is set to report its quarterly results on Wednesday.
In April, Reuters reported that despite being touted as a revolutionary “breakthrough” class of new migraine medicines, a small group of external medical experts who advise US health insurers behind closed doors are not impressed. These experts suggested the trio of drugs offer no clear benefit over existing treatments and recommended that insurers impose limits on their use.
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