The first new class of migraine drugs in decades won FDA approval last year. But the companies who commercialized these new therapies and their potential competitors are already planning new, more convenient versions, taken as pills instead of injectoins just below the skin, and they will present key data in the next few days at the annual meeting of the American Academy of Neurology in Philadelphia.
The new class of migraine drugs are called calcitonin gene-related peptide (CGRP) inhibitors, named for a protein associated with the development of migraine pain. By blocking CGRP, the drugs are meant to abort migraine attacks before they start. In clinical studies, these drugs have shown a reduction in frequency but haven’t completely stopped all migraines.
Migraines affect approximately 39 million people in the US, and 1 billion worldwide, according to the Migraine Research Foundation. Triptans, the last class of migraine drugs to win FDA approval in the 1990s, are pills and injections that treat migraine pain that’s already started. There are preventative therapies, such as Botox injections and drugs prescribed off label. But these treatments don’t work well and can cause serious side effects.
The new (and more expensive) CGRP therapies are drawing more patients into this market, Jefferies analyst David Steinberg wrote in a recent research note. The first three CGRP drugs to come to market are all subcutaneous injections. Patients can dose themselves using injection pens approved for use with each drug. Erenumab (Aimovig) from Amgen (NASDAQ: AMGN), fremanezumab (Ajovy) from Teva Pharmaceutical (NYSE: TEVA), and galcanezumab (Emgality) from Eli Lilly (NYSE: LLY) will have new long-term data at AAN.
That’s important, because heavy advertising and social media campaigns are driving their demand, according to Steinberg. While doctors are reporting positive results, they also told Steinberg that the frequency of side effects such as fingers and toes turning white or blue due to blood circulation problems is also higher than what was reported in clinical trials. Side effects associated with Amgen’s drug include constipation and stomach pain. In such cases, physicians switched patients to either the Teva or Lilly drug. Long-term data should help flesh out the anecdotal picture for both efficacy and safety.
Alder BioPharmaceutical (NASDAQ: ALDR) trails its CGRP rivals. The Bothell, WA, company asked the FDA in February to review its drug eptinezumab. If approved, the company plans a first quarter 2020 launch. But Alder says its drug can set itself apart by working more quickly and lasting longer because it is an infusion into the bloodstream. More of the drug is immediately available to block CGRP, CEO Bob Azelby said during a February conference call.
Infusions, which require a visit to a clinic, and injections aren’t ideal. The door is open to competition from CGRP-blocking pills. SVB Leerink analyst Marc Goodman wrote in a recent research note that the convenience of a pill and long-term safety data would be a welcome alternative to monthly injections. Allergan (NYSE: AGN) is discussing data at AAN for its two CGRP pills. Ubrogepant has been submitted for FDA review in acute migraine, which is treatment after the onset of pain. Allergan will also present Phase 2/3 data for atogepant, which was developed for migraine prevention.
More Phase 3 data for migraine pills is coming from Biohaven (NYSE: BHVN) which has been testing rimegepant in three studies for acute migraine, and from Lilly, which aims to follow its migraine-prevention drug with lasmiditan, a pill developed to treat acute migraine. The data will be closely watched. Information about the safety and efficacy of these drugs has been limited compared with the injectable preventative therapies, RBC Capital Markets analyst Brian Abrahams wrote in a recent research note.
Biohaven plans to file for FDA approval in acute migraine before June 30 and is evaluating rimegepant for migraine prevention in a Phase 3 trial. Lilly submitted lasmiditan for FDA review last November.
Other companies aim to treat migraine with new approaches to old drugs. Impel NeuroPharma has developed a medical device that it says administers an aerosolized drug deep into the nasal cavity—much deeper than typical nasal sprays can reach. In migraine, Impel is testing an inhalable version of the migraine drug dihydroergotamine. Late last year, the privately held Seattle company raised more than $67 million to support clinical trials. Impel is scheduled to present safety and cardiovascular data at AAN about its migraine treatment, which is currently in Phase 3 testing.