Novartis (NVS) has announced results from the five-year, open-label treatment period of a Phase 2 study in episodic migraine prevention showing Aimovig helped patients achieve sustained reductions in monthly migraine days (MMD) and in use of acute migraine-specific medication (AMSM), such as triptans.
Additionally, the safety profile was consistent with the double-blind treatment phase of the study, with no increases in adverse event rates over five years of exposure, says the Swiss drugmaker.
These results are being presented at the Migraine Trust Virtual Symposium.
“These important data highlight the sustained efficacy, safety and tolerability profile of Aimovig, and provide crucial information for patients and doctors managing migraine,” said Dr. Messoud Ashina.
“The study reinforces the potential of Aimovig to reduce monthly migraine days over the long term for people living with this debilitating, yet underdiagnosed disease” he added.
The five-year, open-label treatment phase enrolled 383 patients with episodic migraine who completed a 12-week double-blind, placebo-controlled treatment period (DBTP).
Among the 216 patients who completed the open-label treatment phase, there was an average MMD reduction of 5.3 days from the DBTP baseline of 8.7 days. By the end of the study, patients who used AMSM to treat their migraine headaches experienced an average reduction in AMSM use of 4.4 days from the DBTP baseline of 6.2 days.
The most common side effects were nasopharyngitis, upper respiratory tract infection and influenza.
Additional studies highlighting Aimovig will be presented at the Migraine Trust Virtual Symposium, including interim results of the LIBERTY open-label extension study as well as efficacy and safety results of Aimovig in the EMPOwER study. (See NVS stock analysis on TipRanks)
Aimovig, co-marketed in the U.S. by Amgen (AMGN) and Novartis, is the first and only FDA and EMA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraines.
Shares in Novartis are down almost 8% year-to-date, but the stock scores a firmly bullish Strong Buy Street consensus. That’s with 3 recent buy ratings vs just 1 hold rating. Meanwhile the average analyst price target indicates 21% upside potential lies ahead.
“We think the valuation argument is compelling,” says UBS analyst Laura Sutcliffe. She upgraded the stock to buy on September 11, while ramping her price target to $108, arguing that new products should drive annual earnings growth of a better-than-average 9%.
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