- Teva Pharmaceutical on Friday secured a crucial U.S. approval for its preventive migraine treatment Ajovy, overcoming manufacturing problems at the drug's South Korean supplier which had threatened to further delay regulatory review.
- Ajovy arrives on the market four months after a similar drug from Amgen and Novartis won a first-in-class OK from the Food and Drug Administration in May. Both drugs block a protein known as calcitonin gene-related peptide, or CGRP, and are forecast to become top sellers for their respective developers.
- For Teva, Ajovy is particularly critical. The Israeli drugmaker faces intensifying competition for its blockbuster multiple sclerosis drug Copaxone and has been battered by falling sales of its generic medicines in the U.S. Ajovy, Teva hopes, could be a much-needed salve, although analysts expect Amgen and Novartis' drug to retain a leading market position.
Approval of Ajovy (fremanezumab) ratchets up the competitive pressure on market frontrunner Aimovig (erenuamb), which has enjoyed a strong launch to date.
Both drugs won broad approvals to preventively treat people who experience both chronic and episodic migraine, a population estimated to number in the tens of millions in the U.S. To date, treatment options have been limited to acute medicines such as the now-generic triptan drug class, repurposed medicines and, for those who suffer from chronic migraine, Allergan's Botox (onabotulinumtoxinA).
That opportunity for new treatment options has led Wall Street analysts to predict blockbuster sales for CGRP-blocking drugs. Payers, though, will be a major factor in how well Aimovig, Ajovy and other rivals behind them meet expectations.
When launching Aimovig, Amgen and Novartis set a lower-than-expected price of $6,900 per year, a move widely seen as an effort to secure broad coverage from insurers.
Teva matched that $6,900 price point with Ajovy and plans to offer a savings plan for commercially insured patients to lower the out-of-pocket cost to as little as $0 for an unspecified period of time.
"I think that it's a price that shows that pharma companies are listening to the market, listening to the feedback we're getting from payers," said Brendan O'Grady, head of North America Commercial for Teva, in an interview with BioPharma Dive. "We hope that payers recognize that and will provide relatively open access to these products."
A July report from the Institute for Clinical and Economic Review, a cost watchdog group that's received increasing attention of late, found Aimovig's list price fell within its cost-effectiveness threshold after assuming an industry-average rebate. At the same price, Ajovy could be in a similar range.
O'Grady noted that Teva expects payers to require patients to try generic triptans first before covering use of preventive CGRP inhibitors like Ajovy.
By arriving on market first, Aimovig does enjoy some advantages. A free drug program offered by Amgen for initial patient use has quickly boosted prescription numbers, although sales have yet to add up to much.
Still, Teva believes that Aimovig's four-month head start won't be a significant factor, particularly as payers have yet to set coverage policies for 2019.
A potential wrinkle is the expected entry of a third CGRP inhibitor from Eli Lilly. A decision from the FDA on Emgality (galcanezumab) is expected by the end of September.
Leerink, an investment firm, believes Aimovig will retain a roughly 40% share of the market at peak, with Ajovy fighting Lilly's Emgality for second place.
Clinical studies of the three drugs found all to be broadly effective, reducing the number of monthly migraine days compared to no treatment by about two days per month in both chronic and episodic migraine.
All three are also administered subcutaneously, although Teva's will be offered on both a monthly and a quarterly dosing schedule.
"I think that that's a key differentiator," O'Grady said. "To be able to offer that real world flexibility of monthly or quarterly dosing, we think is important."
Ajovy will be available commercially in two weeks. For Teva, hampered by falling sales in the U.S. and a large debt burden, launch cannot come soon enough.