Lilly's migraine drug wins US approval, pressuring rivals Amgen, Teva
- Eli Lilly became the third drugmaker to win U.S. approval for a new type of preventive migraine treatment Thursday, making the emerging market for the medicines one of the most quickly competitive in the industry.
- Emgality, as Lilly's drug will be sold, joins rival therapies from Teva and the team of Amgen and Novartis as new options for the millions of Americans estimated to suffer from the debilitating headache condition. All three target a protein known as calcitonin gene-related peptide, or CGRP, that's involved in migraine attacks.
- Lilly priced Emgality at a wholesale cost of $6,900 per year, matching the price points set first by Amgen and then Teva for their respective drugs. With roughly similar clinical profiles between the three, the focus now shifts to how insurers will respond.
Just four months have passed since Amgen and Novartis won a first-in-class OK from the Food and Drug Administration for Aimovig (erenumab) in May.
Prior to the drug's approval, migraine sufferers had not seen a new treatment option since Allergan's multipurpose Botox (onabotulinumtoxinA) cleared regulators' desks in 2010 for chronic forms of the condition.
Now, three branded biologics are jostling to win over physicians and patients who've been waiting for better therapies.
While fleeting, that four-month lead allowed Amgen and Novartis to set the terms of competition for what is now a crowded market. Pricing Aimovig at an annual cost of $6,900 surprised market analysts, some of whom had expected a cost approaching $10,000 per year.
The decisions by Teva and Lilly to follow suit underscores that commercial success in migraine will largely be determined by access to therapy, placing power in the hands of insurers tasked with deciding how to cover the drugs.
Analysts expect each to become blockbusters in their own right in time, although current forecasts generally favor Aimovig to emerge as the market leader.
Anti-CGRP class shaping up to be competitive
|Drug||Company||Dosing||Est. 2020 US sales (millions)||Est. peak market share|
|Aimovig||Amgen, Novartis||Monthly via autoinjector||$917||38%|
|Ajovy||Teva||Monthly or quarterly via pre-filled syringe||$228||20%|
|Emgality||Eli Lilly||Monthly via autoinjector||$296||24%|
|eptinezumab||Alder||Quarterly via intravenous infusion||$46||19%|
SOURCE: Companies, Leerink estimates
Amgen and Novartis initially provided Aimovig free to patients for two months — a decision that's resulted in rapid uptake of the drug but little in revenue.
Lilly will up the ante, announcing alongside Emgality (galcanezumab)'s approval a program that will give migraine patients on commercial insurance a year of free treatment. It's a bold step that suggests Lilly views initially attracting patients as critical to its long-term success.
The Indianapolis-based pharma expects to eventually secure broad coverage of Emgality. In the meantime, its sampling program could help blunt the impact of Amgen and Novartis' head start.
"We are in late-stage discussions with every major payer nationally," said Wei-Li Shao, a vice president at Lilly's neuroscience unit, in an interview with BioPharma Dive ahead of the FDA's decision.
It's not yet clear whether payers will seek exclusive contracts or extensive rebates in return for coverage. At least one payer, Express Scripts, previously encouraged migraine drugmakers to price lower from the start rather than rely on standard industry practices of pricing high and winning contracts through rebating.
Competition could also prompt drugmakers to test value-based contracts, like Amgen and Sanofi have in the PCSK9 inhibitor space.
"It could be a great category for some value and outcomes-based pricing approaches," said Dan Skovronsky, head of Lilly's research labs, in a July earnings call.
In pitching Emgality, Lilly is also emphasizing clinical results which showed treatment with the drug led to migraine freedom in about 1 in 7 patients with episodic migraine.
All three drugs were proven to reduce the number of monthly migraine days by about two days versus placebo. Lilly, however, believes the efficacy seen in high responders to Emgality could help its drug stand out.
"We think we have a best-in-class product," Shao said.
For the majority of patients who still experience migraine attacks while on preventive anti-CGRP therapy, though, acute treatments will likely still be needed.
Initially, pent-up demand might lift all three therapies. But Lilly's confidence will be tested by a marketplace that's pushing all three drugmakers to court payers and patients.
- BioPharma Dive Will Ajovy lead Teva's turnaround?
- BioPharma Dive Aimovig launch bolsters hopes for blockbuster sales
- BioPharma Dive Prior authorization limits would be 'reasonable' for CGRP drugs, ICER says
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