Eli Lilly scored another win against diabetes as the company’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide won approval under Priority Review from the U.S. Food and Drug Administration.
Less than one month after the U.S. Food and Drug Administration raised concerns about the supplemental New Drug Application for Pfizer and Myovant Sciences’ Myfembree (relugolix), the regulatory agency extended the review period to Aug. 6. The initial approval review date was May 6.
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
The U.S. Food and Drug Administration approved Phathom Pharmaceuticals Inc.’s Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules) for the treatment of Helicobacter pylori infection in adults.
The U.S. Food and Drug Administration granted full approval to Orphalan’s Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s disease, a rare genetic disorder. The approval announcement marks the first new treatment available for patients in over five decades.
The U.S. Food and Drug Administration expanded the indication of Supernus Pharmaceuticals Inc.’s Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.
The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s oral heart disease drug, making Camzyos (mavacamten) the first cardiac myosin inhibitor to be permitted for use in the country.
AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).
Amneal Pharmaceuticals received the green light from the U.S. Food and Drug Administration for bevacizumab-maly, a biosimilar to Roche/Genentech’s Avastin. The biosimilar approval marks the second for Amneal during 2022.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.