Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
Calliditas Therapeutics AB’s full approval from the U.S. FDA for Tarpeyo (budesonide) delayed release capsules in immunoglobulin A nephropathy (IgAN) revived speculation about competitor Travere Therapeutics Inc. which, like Calliditas, has gained accelerated approval for its prospect.
Calliditas Therapeutics AB expects its oral version of budesonide to be available early in the first quarter of 2022, following FDA approval for treating patients with progressive kidney disease primary immunoglobulin A nephropathy (IgAN). Branded Tarpeyo, the delayed-release capsules were cleared for use in reducing proteinuria in adults with primary IgAN at risk of rapid disease progression, usually determined as a protein-to-creatinine ration (UPCR) of 1.5 g/g or less.
Astrazeneca plc is eyeing an addition to its respiratory diseases portfolio after a potential first-in-class “rescue” asthma inhaler, PT-027, met its goals in two phase III trials.
Sweden’s Calliditas Therapeutics AB has licensed its rare kidney disease therapy to Stada Arzneimittel AG in Europe to help it navigate the complexity of the region’s market, ahead of a potential European and U.S. approval in the coming months.
Calliditas Therapeutics AB, filled with confidence by positive top-line results from a phase III trial of its oral budesonide, Nefecon, in patients with primary immunoglobulin A nephropathy (IgAN), said it plans to seek accelerated approval for the drug from the FDA in the first quarter of 2021.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.