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FDA Approves Novel Therapy to Prevent Migraine
AbbVie’s Qulipta is a once-daily oral to prevent migraines in adults.
The approval is based on data from a clinical trial program that evaluated Qulipta in almost 2,000 patients who experienced four to 14 migraine days per month, including the pivotal phase 3 ADVANCE study — which was published in The New England Journal of Medicine in August 2021— the pivotal Phase 2b/3 study, and the Phase 3 long-term safety study.
In the ADVANCE trial, all dosage groups met the primary end point and demonstrated statistically significant reductions in mean monthly migraine days compared with placebo. Patients treated with 60 mg of Qulipta across 12 weeks experienced a 4.2-day reduction from baseline of 7.8.
A secondary end point in this trial measured the proportion of patients that achieved a more than a 50% reduction in monthly migraine days across the 12-week treatment period. The trial demonstrated that in all the three dosage strengths — 10 mg/30 mg/60 mg arms — achieved a 50% to 100% reduction, compared with 29% of patients in the placebo arm.
Michael Severino, M.D.
“Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating. Qulipta can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously,” Michael Severino, M.D., vice chairman and president, AbbVie, said in a statement.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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