Novartis/Amgen's migraine drug excites with phase 3 data

Novartis and Amgen’s migraine drug erenumab has got a further boost with new phase 3 data showing it halved migraine days in 50% of patients.

The companies published top line results from STRIVE around a year ago, but they have now lifted the lid on the details of the study used as a basis for filings in the US and EU.

Erenumab will be branded as Aimovig and is from the calcitonin gene related peptide (CGRP) class of drugs, with several competitor antibodies from different companies approaching the market.

Novartis and Amgen have taken the lead, but Teva’s fremanezumab is close behind, along with Eli Lilly’s galcanezumab and Alder’s eptinezumab.

These are the first fully reported phase 3 results from a drug in the CGRP class, putting Novartis and Amgen in pole position in the race to get to market.

The FDA is due to make a regulatory decision on erenumab next May, and a decision from EU regulators is due later in 2018. Teva filed fremanezumab with the FDA last month.

Among the group, erenumab is the only fully human monoclonal antibody, designed to reduce side effects associated with the competitors, which have been humanised.

STRIVE enrolled 955 patients, who were randomised to receive either placebo or subcutaneous erenumab 70mg or 140mg once a month, for six months.

Patients taking erenumab at the higher dose experienced a significant 3.7-day reduction in monthly migraine days from the baseline of 8.3 days.

Those on the 70mg dose saw a 3.2 day reduction, while those on placebo saw a 1.8 day reduction.

Fifty percent of patients taking erenumab 140mg had their migraine days cut by at least half, representing a significantly higher likelihood of achieving this response compared to placebo.

On the lower dose, 43.3% had their migraine days cut by at least half, compared with 26.6% on placebo.

Erenumab could bring in sales of almost $500 million in 2022 if approved, although analysts say Teva’s fremanezumab could push through the billion-dollars a year mark.

If approved, Novartis will co-market erenumab in the US, while Amgen has exclusive rights in Japan. Novartis has exclusive rights to market the drug in the rest of the world.