logo
  

FDA Approves AbbVie's Qulipta For Preventive Treatment Of Migraine

The U.S. Food and Drug Administration approved AbbVie's (ABBV) Qulipta or atogepant for the preventive treatment of episodic migraine in adults.

Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine, the company said in a statement.

The approval is supported by data from a clinical program evaluating the efficacy, safety and tolerability of QULIPTA in nearly 2,000 patients who experienced 4 to 14 migraine days per month, including the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study, and the Phase 3 long-term safety study.

AbbVie noted that Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days among adults with episodic migraine compared to placebo across the 12-week treatment period with significant reductions seen in weeks 1-4.

The pivotal trial showed that when taking Qulipta, the majority of patients experienced between a 50-100% reduction in monthly migraine days across 12 week.

Migraine is a complex disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea. It is highly prevalent, affecting more than 1 billion people worldwide, including 39 million people in the U.S. alone.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Teleflex Inc., a provider of medical technologies for critical care and surgery, is recalling Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR, the U.S. Food and Drug Administration said. The Arrow-Trerotola Percutaneous Thrombolytic Device or PTD Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous or AV... Privately-held biotechnology company On Target Laboratories, Inc. announce that the U.S. Food and Drug Administration or FDA, has approved Cytalux (pafolacianine) for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. Cytalux is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively. The Federal Trade Commission or FTC has ordered Walmart, Amazon, Kroger and certain other large wholesalers and suppliers to provide information to help it study causes of supply chain disruptions. The agency has launched an inquiry to find the reasons for empty shelves and exorbitant prices. Along with Walmart, Amazon.com, and Kroger, the order has been sent to C&S Wholesale Grocers, Associated..
Follow RTT