The first wave of a new class of migraine prevention drugs brought patients a way to reduce the frequency of their debilitating headaches, albeit with an injection. An AbbVie drug in more convenient pill form is now FDA approved, the second oral therapy that the FDA has authorized for migraine prevention this year.
Migraine is classified according to headache frequency. The far more prevalent episodic migraine is defined as fewer than 15 headache days per month. Chronic migraine means 15 or more headache days each month. The FDA approved the AbbVie drug, atogepant, for preventing episodic migraine in adults. North Chicago, Illinois-based AbbVie will market the once-daily pill under the name Qulipta.
The AbbVie drug is the latest product in a new class of drugs called calcitonin gene-related peptide (CGRP) inhibitors. CGRP and receptors for this protein are expressed throughout the parts of the nervous system associated with how migraine develops. Research has found that CGRP levels are elevated during migraine attacks, leading several companies to pursue it as a drug target. In 2018, Amgen won the first FDA approval of a CGRP blocking drug, Aimovig. Eli Lilly and Teva Pharmaceutical secured approvals for their CGRP drugs later that year; an Alder BioPharmaceuticals (now part of Lundbeck) drug was approved last year. All of them are antibodies that must be given monthly or once every three months; the Amgen, Lilly and Teva drugs are injections while the Lundbeck product is an infusion that must be administered in a clinical setting. [Paragraph updated to clarify the routes of administration of the drugs.]
The first oral CGRP drug that reached the market was Allergan’s Ubrelvy, which was approved in 2019 for acute migraine, which means treating the headache at the onset of an attack. That drug is now an AbbVie product, added with the $63 billion acquisition of Allergan last year. The deal brought along two other migraine assets. Botox injections have been FDA approved for migraine prevention for more than a decade. At the time of the acquisition, the drug that would become Qulipta was still in late-stage clinical development under Allergan.
Blocking CGRP does not prevent migraine attacks entirely, but clinical research across the CGRP drug class has shown that this approach reduces their frequency. FDA approval of Qulipta was based on the results of a placebo-controlled Phase 3 study enrolling 910 patients. Patients were randomly assigned to receive one of three doses of the pill, or a placebo, for 12 weeks. The main goal was to show a reduction in the average number of migraine days per month.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
According to data released last year, all three doses showed a statistically significant reduction in headache days compared to the placebo group. Adverse reactions included nausea, constipation, fatigue and sleepiness, and loss of appetite. Full results from the Phase 3 clinical trial were published last month in the New England Journal of Medicine.
With the regulatory nod now secure, Qulipta is set to compete against Nurtec, an oral CGRP migraine drug marketed by Biohaven Pharmaceuticals. The Biohaven drug, a tablet that disintegrates on or under the tongue, was first approved last year as a treatment for acute migraine. In May, the FDA approved migraine prevention as an additional indication for Nurtec. The drug generated nearly $93 million in revenue in the second quarter of this year.
FDA approval of Qulipta covers three strengths: 10 mg, 30 mg, and 60 mg. AbbVie said its new migraine drug will become available by early October.
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