AbbVie pressures Biohaven in migraine prevention with FDA approval for its CGRP blockbuster-to-be Qulipta

Doctors expect Qulipta’s launch won’t eat into Nurtec’s share but rather will erode share from injectable CGRPs and other generic medicines, a recent survey by Piper Sandler showed. (AbbVie)

The race for supremacy is officially on among oral CGRP inhibitors to prevent migraine.

Tuesday, AbbVie said the FDA has green-lighted its Qulipta, or atogepant, for prevention of episodic migraine. The go-ahead follows the landmark approval of Biohaven’s Nurtec ODT as the first oral anti-CGRP drug for preventing migraine, setting up a direct battle between two meds that both bear big sales expectations.

For Qulipta, SVB Leerink analyst Geoffrey Porges in August projected about $1.2 billion sales in 2030, which he noted was above Wall Street’s consensus estimates of $1 billion. Piper Sandler’s Christopher Raymond is even more optimistic; in a note on Monday, he noted that the AbbVie drug could hit $1 billion in 2025.

The two analysts based their Qulipta analyses on the CGRP drug’s clinical data and physician feedback.

In the phase 3 Advance trial, all three Qulipta doses showed significant reductions in average days a patient experienced migraine per month over placebo. At the highest 60-mg dose, Qulipta reduced the average monthly migraine days by 4.2 days, while placebo patients experienced a decrease of 2.5 days. This Qulipta dataset is roughly in line with its competitors', but the AbbVie drug “performed well above peers” in terms of the percentage of patients who achieved over 50% reduction in average monthly migraine days, Porges pointed out in an August note.

RELATED: With latest FDA nod, Biohaven's Nurtec becomes first migraine med to prevent—and treat—attacks

Before Biohaven’s Nurtec, only injectable and infusion CGRP agents were available for migraine prevention, including Amgen’s Aimovig, Eli Lilly’s Emgality, Teva’s Ajovy and Lundbeck’s Vyepti. But none of them has been able to dominate the market, Porges noted.

Doctors’ initial feedback for Nurtec suggests a strong launch for the Biohaven med in the prevention setting. A recent survey of 100 neurologists Raymond’s team conducted with Spherix Global Insights indicated that Nurtec has captured 6% of the episodic migraine prevention market merely four months into its FDA go-ahead. That’s compared to 11% for Aimovig and 9% for Emgality.

What’s more, Nurtec attracted a 5% share among chronic prevention patients, even though it’s not approved there. AbbVie is also evaluating Qulipta for chronic migraine prevention, with registrational data and a potential regulatory filing expected next year.

When asked about their interest in pipeline drugs, the doctors put Qulipta as their favorite, with nearly half describing it as their most desired upcoming option, Raymond’s Monday note shows.

Interestingly, the doctors expect Qulipta’s launch won’t eat into Nurtec’s share but will rather erode share from injectable CGRPs and other generic medicines, Raymond noted.

Compared with the injectables and Nurtec, Qulipta showed an increased rate of constipation in its clinical trials, which Porges argued might hurt its duration of treatment and also its position in the sequence of treatment.

RELATED: Biohaven's Nurtec ODT outmuscles AbbVie's Ubrelvy in gaining new migraine patients following key FDA nod

Qulipta’s approval arrives as Nurtec has started to outpace AbbVie’s other oral CGRP, Ubrelvy, in the acute treatment setting. With the migraine prevention expansion in May, Nurtec’s FDA label allows for both acute and preventive therapy in the same patient. Doctors apparently like that flexibility, as most docs in Raymond’s survey listed Nurtec as their top choice for acute treatment.

More broadly, Qulipta’s approval is a much-needed win for AbbVie. The Illinois pharma suffered a setback recently as its up-and-coming immunology star Rinvoq was slapped with an FDA class-wide boxed warning about risks of serious heart-related events, cancer, blood clots and death. The agency also pushed its use—along with several other oral JAK inhibitors—behind traditional TNF blockers.

Industry watchers have suggested the move could hurt the drug’s opportunity in some of the biggest indications such as rheumatoid arthritis and atopic dermatitis, which is still awaiting an FDA decision.