Data keeps Lilly in race for new migraine treatment

Positive data from three late-stage studies of Lilly’s galcanezumab has kept the company in the race to develop a migraine drug in the promising new CGRP inhibitor class.

With galcanezumab,  Lilly is attempting to develop a calcitonin gene-related peptide receptor inhibitor, a drug class also targeted by Teva, Amgen/Novartis, and Alder Biopharmaceuticals. Late-stage results from galcanezumab in a second cluster headache indication are due next year.

Lilly has been finding it tough to develop new drugs, after the FDA rejected its rheumatoid arthritis pill, baricitinib, in April, and the high-profile late-stage trial failure of Alzheimer’s drug solanezumab late last year.

So the data from galcanezumab will be most welcome, and could prove to be a solid, but not stellar performer if approved. The company needs new revenue streams following patent expiry on big-selling drugs such as antidepressant Cymbalta (duloxetene).

Amgen and Novartis published data from their CGRP inhibitor erenumab six months ago and last month reworked a licensing agreement, agreeing to co-commercialise the drug in the US, with Novartis getting rights for the rest of the world except Japan.

According to Evaluate Pharma, Teva’s TEV-48125 is the most fancied by analysts, who forecast sales of just over $1 billion a year in 2022, with Alder’s eptinezumab expected to be not far behind.

Galcanezumab is forecast to produce sales of $484 million in 2022, with Erenumab raking in around $475 million.

In the two EVOLVE studies, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo.

In EVOLVE-1 there was an average reduction of 4.7 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.8 days for placebo.

EVOLVE-2 showed an average reduction of 4.3 days for 120 mg and 4.2 days for 240 mg compared to an average reduction of 2.3 days for placebo.

Patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.

Over the three-month treatment period in the REGAIN study, patients with chronic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo.

According to REGAIN there was an average reduction of 4.8 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.7 days for placebo.

Patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.

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