Teva scraps development of CGRP inhibitor Ajovy in cluster headaches

Teva said Tuesday that it will end development of Ajovy (fremanezumab) in cluster headaches after a pre-specified futility analysis of a Phase III study in episodic cluster headache revealed that the trial’s primary endpoint is unlikely to be met. The company also stopped a chronic cluster headache study of the CGRP inhibitor in June last year following a futility analysis. 

Specifically, the latest analysis found that Ajovy was unlikely to significantly reduce the weekly average number of cluster headache attacks versus baseline over the four-week treatment period. Teva said that as a result, it is discontinuing the ENFORCE Phase III clinical trial programme of the drug, which also includes a long-term safety study.

Ajovy gained FDA approval in September 2018, making it the first anti-CGRP treatment with both quarterly and monthly dosing for the prevention of migraine in adults, while the therapy was authorised in Europe earlier this month. Teva noted that it is continuing to investigate Ajovy in other indications, including a Phase II study for the treatment of post-traumatic headache. 

Sales of Ajovy for the fourth quarter of 2018 reached $3 million, with Teva targeting about $150 million in revenue from the product this year. There are a number of other CGRP inhibitors on the market, with CVS Health announcing in January that it would exclusively cover Ajovy and Eli Lilly's Emgality (galcanezumab), while UnitedHealth's Optum unit later indicated that it would exclude Teva's drug from its formulary in favour of Emgality and Amgen's Aimovig (erenumab) (for related analysis, see ViewPoints: CVS confirms PBMs will be a headache for anti-CGRP companies).

Meanwhile, the FDA granted priority review last month to Eli Lilly's filing seeking clearance of Emgality for the preventive treatment of episodic cluster headache in adults. BMO Capital Markets analyst Alex Arfaei said that Teva's decision to end development of Ajovy in cluster headaches could help Eli Lilly differentiate its drug from similar therapies. "Although the cluster headache market is much smaller than the migraine market, it is a high unmet need, and Lilly should be able to leverage its positive cluster headache data to differentiate Emgality."

For additional analysis of the CGRP market, read KOL Views Results: Aimovig has first-mover edge but anti-CGRP battle wide open, says leading headache specialist, and Physician Views Results: European prescribers split on credentials of new migraine prevention therapies.

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