Lilly and Alder showcase latest migraine drug data

A gang of new migraine drugs are nearing approval, and new data is emerging from contenders from Eli Lilly, and its upstart rival Alder Biopharmaceuticals as they prepare their bids for a highly competitive market.

With Novartis/Amgen leading the pack and the FDA and Teva snapping at its heels, the companies are aiming to revolutionise care of the condition with drugs from the calcitonin gene-related peptide class.

The FDA is due to make decisions with regard to Amgen and Novartis’ Aimovig in May, and Teva’s fremanezumab in June.

Lilly expects an FDA decision on its galcanezumab in the third quarter, and Alder, a small biotech from Washington State is aiming to file its eptinezumab later in the year.

Data on the characteristics of the drugs are emerging at the American Academy of Neurology annual meeting in Los Angeles as the companies make the case for their various drugs.

Lilly has a new analysis from three phase 3 studies that it is using as a basis for its filing of galcanezumab.

The subgroup analysis shows that galcanezumab is effective in patients with episodic and chronic migraine who previously responded to two or more preventive therapies.

Christi Shaw, president of Lilly Bio-Medicines said the data is important as nearly half of migraine patients stop their prescribed therapies within sixty days of prescription, often due to side effects or lack of efficacy.

"The research presented today on galcanezumab validates Lilly’s decades-long effort to bring a new therapy to market that has the potential to help people experience more migraine-free days, regardless of past preventive therapy use," said Shaw.

And Alder presented phase 3 data from the PROMISE 1 trial, showing the drug is effective in the longer term.

The 12-month data  showed patients experienced further reductions in migraine  following third and fourth quarterly infusions at both dose levels (100mg and 300mg) of eptinezumab.

Results showed 70% of patients achieved an average 50% reduction or greater of monthly migraine days from baseline, compared with 58.7% for placebo. This represents an 8.9% improvement from reductions experienced during the first two quarterly doses.

And 51.5% of patients achieved a 75% reduction or greater of monthly migraine days compared with 39.7% on placebo. This is a 12.8% improvement from reductions experienced during the first two quarterly doses.

Alder’s drug is less fancied by analysts because it is given intravenously, requiring a visit to the clinic.

Matthew Robbins, associate professor of neurology at Albert Einstein College of Medicine, who was not involved in the trial, told Neurology Today that the difference between the placebo and treatment arms could be down to population effect where some patients on the drug responded well, but others did not.

"It proves the principle that CGRP is important for migraine. People do better as a whole," he told the journal after watching Alder’s presentation at the conference.

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