Claiming it would be impossible to carve out a so-called skinny label that would comply with generic drug “same labeling” rules, Novartis AG is petitioning the U.S. FDA, for the second time, not to approve generic versions of its blockbuster heart drug, Entresto (sacubitril + valsartan), that attempt to carve around a cardiovascular indication that has exclusivity until Feb. 16, 2024.
In an effort to get drug regulators in the various EU member states on the same page, the EMA issued a Sept. 19 statement confirming that all biosimilars approved in the EU are interchangeable with other approved biosimilars referencing the same biologic, as well as the reference biologic itself.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Nanotherapies, Concept Medical, Rheonix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Agios, Astrazeneca, Belite, Biontech, Gilead, Kite, Marengo, Merck & Co., Novavax, Pfizer, Sanofi, Stada, Takeda, Xbrane.
Bluebird Bio Inc.’s elivaldogene autotemcel (eli-cel) gained U.S. approval late Sept. 16 for use in early active cerebral adrenoleukodystrophy (CALD), making it the firm’s second gene therapy to clear the FDA in as many months. Branded Skysona, eli-cel is expected to be available commercially by the end of 2022 and its launch will require only “incremental” company resources on top of those required for the ongoing launch of beta-thalassemia gene therapy Zynteglo (betibeglogene autotemcel), Bluebird said.
What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective.
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qiagen, Sirtex Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aro, Candel, Inversago, Jasper, Kymera, Lipocine, Mallinckrodt.
With four complete response letters behind it and seven months ahead of its April 2023 PDUFA date, Mallinckrodt plc’s Terlivaz (terlipressin) has been approved by the U.S. FDA for treating hepatorenal syndrome. Terlivaz had a decade-long series of obstacles before getting the long-awaited approval. The vasopressin analogue selective for V1 receptors was approved, in part, on results from the phase III CONFIRM trial of 300 patients, which met its primary endpoint of renal function improvement, avoidance of dialysis and short-term survival (p=0.012).
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