Teva abandons Ajovy's cluster headache ambitions, clearing a path for Lilly to forge a new market

When Teva won FDA approval for its migraine drug Ajovy last September—becoming the second of three companies to enter the hot new market for CGRP inhibitors—the Israeli company hoped for a quick launch that would help fuel its turnaround efforts. But now Ajovy’s growth potential is very much in question.

Teva is ditching its plans for Ajovy in cluster headaches, the company said Tuesday, after an early phase 3 trial analysis showed it was unlikely to hit its primary endpoint. And that exit not only casts a cloud over Ajovy, but also paves a smoother path for one its CGRP rivals, Eli Lilly.

In November, Lilly's CGRP entrant Emgality nabbed Breakthrough Therapy Designation in cluster headache after phase 3 data turned up positive. Emgality patients had nearly nine fewer days with cluster headaches between weeks one and three of a two-month treatment period, the study showed, compared with five fewer headache days in placebo patients. Emgality then nabbed an FDA priority review in March, putting it on track for potential approval in September.

The ability to pitch CGRP inhibitors outside the migraine field could be important as Lilly and Teva—and their fellow CGRP rival Amgen, which hit the market first with its Novartis-partnered entrant, Aimovig—jockey for share. 

Teva is already struggling in one key area: insurance reimbursement. In February, UnitedHealthcare PBM OptumRx left Ajovy off its preferred formulary, so patients who choose the Teva brand will have to pay more for it than they would for the Lilly or Amgen meds. And that was Teva’s second payer defeat: Express Scripts, now owned by Cigna, also excluded Ajovy from its preferred list.

RELATED: When 2 out of 3 is bad: Teva migraine drug gets sidelined in second PBM's formulary

JPMorgan analysts cited Teva’s reimbursement challenges as an obstacle in a Tuesday report that sizes up the CGRP field's first year on the market. “[G]ross-to-net and payer coverage dynamics [will] remain a focus for Ajovy given its fairly narrow reimbursed coverage relative to competitors,” the report predicted.

One emerging issue could play in Teva’s favor, though: side effects. Physicians are reporting constipation as a problem for many Aimovig patients, according to the JPMorgan analysts. That could drive patients toward Lilly and Teva going forward, the analysts said.

JPMorgan surveyed 25 physicians who treat migraines and came away with bullish predictions about the future of the market. The physicians reported that over 70% of patients prescribed a CGRP inhibitor to prevent migraines have stayed on the treatments. The surveyed physicians expect use of the drugs in chronic migraine patients will jump from 18% today to 40% in three years.

JPMorgan estimates that all three drugs will each reap more than $1 billion in annual sales by 2023, but that Teva will be in third place. Even with payers pressuring all three players, “volume trends for the category are exceeding our expectations and our overall view on the size of the CGRP opportunity has not significantly changed,” the firm’s report said.

RELATED: Don't fret about Lilly's 3rd-to-market start in CGRP, executive says. It's got big plans in migraine and pain

Despite Lilly’s third-to-market status in CGRP inhibition, the company has come out fighting. Its sales force has been touting Emgality's easy-to-use injector and citing efficacy advantages the company believes were borne out in its clinical trials and labeling, Lilly Bio-Medicines President Christi Shaw told FiercePharma in January.

With earnings season in full swing, the CGRP drugs will be in the spotlight over the coming days. No doubt executives from Lilly and Amgen will be peppered with questions about how their drugs are performing when they both report first-quarter earnings on April 30. Teva will get its chance to quell concerns about Ajovy’s future when it reports earnings on May 2.