Lilly chases Amgen with migraine drug filing

Eli Lilly has filed its galcanezumab migraine drug with the FDA, as it looks to claim second place among a group of companies attempting to market a new class of therapies.

Novartis and Amgen already filed their migraine drug Aimovig (erenumab) with the FDA in late July, the first from the calcitonin gene-related peptide (CGRP) inhibitor class to get a review.

Lilly has now had its filing for its rival CGRP accepted by the FDA, which will review data from three phase 3 studies, EVOLVE-1, EVOLVE-2 and REGAIN, involving 2,901 patients.

The company said that in these studies, patients treated with galcanezumab experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to placebo. The most commonly-reported adverse events were injection site reactions, including pain.

Teva is also poised to file its CGRP migraine drug, fremanezumab, with the FDA, while Alder BioPharmaceuticals is bringing up the rear with its eptinezumab.

Analysts EvaluatePharma forecast that Teva’s drug has the highest sales potential, generating just over $1 billion in 2022, when Alder’s will also be approaching the billion-dollar barrier.

According to Evaluate sales of galcanazeumab will be $484m by 2022, while erenumab will be generating $484 million.

Galcanezumab represents the first of three investigational, non-opioid treatments in development as part of Lilly's overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer, for the treatment of osteoarthritis, chronic low back pain and cancer pain.

Cyramza disappointment

The news came after Lilly said it would not file its Cyramza (ramucirumab) in stomach cancer after a late-stage trial disappointment.

Lilly said top-line phase 3 study results showed it stayed progression of the disease but failed to show an overall survival benefit.

The RAINFALL study of Cyramza combined with cisplatin and capecitabine or 5-FU chemotherapy in first line HER-2 negative metastatic gastric or gastroesophageal junction adenocarcinoma met a progression-free survival primary endpoint, but not an overall survival endpoint.

Lilly was hoping that Cyramza would provide the first major advance over standard chemotherapy in this type of cancer in the last decade.

Cyramza is already approved in other gastric, lung and colorectal cancer indications.