The Food and Drug Administration approved Ubrelvy, the company’s ubrogepant treatment, on Monday. The oral medication is aimed at treating migraines in patients who are unresponsive to common migraine treatments, such as triptans, or are at risk of cardiovascular disorders. Allergan, which anticipated a December approval by the FDA, said Ubrelvy will be available for sale in the U.S. in the first quarter.
The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.
Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ also received approval by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.
For those who suffer from insomnia, the answer is not simple. Of the few medications on the market, many cause a slew of unpleasant and sometimes dangerous side effects. However, recently the FDA approved a new insomnia medication that may serve as an alternative. The drug, named lemborexant (Dayvigo), was found to particularly help seniors stay asleep.
“Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions,” said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.
One of Eli Lilly's drugs, Trijardy XR, was approved by the FDA this week, and top-line results were announced from a Phase 3 clinical trial for another. Trijardy XR combines three type 2 diabetes medications into one pill that, combined with diet and exercise, lowers blood-sugar levels in adults. This combination of different diabetes medications marks an important advancement in the treatment of the disease.
Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK™ (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial.
Illumina has appointed Scott Gottlieb to its board of directors. Gottlieb is currently a special partner at New Enterprises Associates and a resident fellow at the American Enterprise Institute. He previously served as the 23rd commissioner of the US Food and Drug Administration form 2017 to 2019. Prior to joining the US FDA as commissioner, Gottlieb was a clinical assistant professor at the New York University School of Medicine.
And the costs of the inefficient, error-prone process that is drug discovery are not only high but increasing. Where Moore’s Law illustrates the cheapening and "easy access" of digitization in many technology fields, the pharmaceutical industry has the cleverly named Eroom’s Law ("Moore" spelled backward), described by Jack Scannell and team in 2012, that shows that the number of new drugs approved by the FDA per billion U.S. dollars (inflation-adjusted) spent on R&D has halved roughly every 9 years.
This is not to say that no startups are working to commercialize this technology. Last year, CureMetrix became the first company to receive FDA approval for its AI-based breast cancer technology; the company plans to deploy in several clinical settings this year. Other startups angling to commercialize and scale AI-based radiology in the near term include Arterys, Aidoc, Zebra Technologies and DeepHealth.
Last year Jewell spent most of the year cracking the US; its first batch sold out in two weeks and the second delivery should be stateside next week, Jewell says. Building a relationship with online behemoth Amazon was the easy bit, but getting the tick of approval from regulatory agency the US Food and Drug Administration was not. The barcode had to be shifted to the other side of the label, for example. Everything had to be converted to ounces. The language used is US-English, not English – not major hurdles, but when everything Fix and Fogg does is done in-house rather than contracted out, it all adds up.