Market, Regulatory

Allergan set to make headway in crowded CGRP migraine market, as the battle for formulary coverage begins

Millions of migraine sufferers could soon get their hands on an oral CGRP drug designed to be used as-needed, as Allergan $AGN on Wednesday said it was on track to file for FDA approval for ubrogepant in the first quarter of next year. The multi-billion dollar migraine market is already replete with injectable medications from Teva $TEVA, Eli Lilly $LLY, and one from Amgen $AMGN and Novartis $NVS, which are all designed to be used as preventative treatments and are curiously priced identically.

Last month, Lilly secured FDA approval for its injection Emgality, after the agency granted similar approvals to Aimovig from Amgen Inc and Novartis, and Teva’s Ajovy. All three drugs largely work in a similar manner and have demonstrated a significant reduction in migraine frequency in about half of patients when tested in clinical studies. Interestingly, each drugmaker has also priced their offerings at a list price of $6,900 a year, or $575 per month.

But earlier on Wednesday, Reuters reported that the hefty US pharmacy benefit manager Express Scripts $ESRX had decided to cover new migraine drugs from Lilly and Amgen as part of its formulary and exclude Teva, following negotiations with all three manufacturers.

“This puts more pressure on Teva to score formulary wins in the other larger plans, which at this point may still be up for grabs. We estimate peak share of 20% for Ajovy but acknowledge it will be imperative for it to get 1-2 major wins to get there,” Leerink analysts wrote in a note.

Teva shares are down 5%.

A spokesperson from Allergan told Endpoints News that it was premature to comment on ubrogepant’s pricing and payer discussions as the company has not yet filed its marketing application, and that it could not comment on its plans for an EMA filing at this time.

According to the Migraine Research Foundation, migraine is the third most prevalent illness in the world, affecting about 39 million in the United States and some 1 billion worldwide. The market for migraine drugs is expected to hit $8.7 billion by 2026, according to Globaldata.  Before the slate of approvals this year, patients were largely treated with a host of drugs including anti-depressants, hypertension medicines and a class of drugs called triptans. This new class of biologics, known as CGRP (calcitonin gene-related peptide) inhibitors, target the CGRP protein that transmits pain signals into the brain, and is believed to be instrumental in generating and maintaining headaches associated with migraine.

For those patients who still experience migraine attacks while on preventative anti-CGRP therapy, acute, as-needed treatments will still be required, which is where Allergen’s ubrogepant, which the company acquired from Merck $MRK in 2015, could come handy.

If approved, ubrogepant could potentially be used in combination with its anti-CGRP injectable rivals and/or Allergan’s own versatile Botox injection, which has been approved for migraine prevention since 2010.

Allergan has already reported positive Phase III data on ubrogepant from two studies earlier this year, and on Wednesday said that two other studies further evaluating the drug’s safety and tolerability, including one which evaluated the potential of hepatic toxicity in healthy patients, meant that it was on track to file in Q1, 2019. Migraine drug developer, Biohaven $BHVN, however is doing their safety study in migraine patients, as Evercore’s Umer Raffat points out.

Both Biohaven and Alder $ALDR are poised to submit their migraine drugs for marketing approval next year.


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