June 14 Quick Takes: ICER weighs in on Amylyx’s ALS treatment
Plus EQRx’s first regulatory submission, WHO to discuss monkeypox status and updates from PureTech, Tilt and more
An amyotrophic lateral sclerosis therapy from Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) would “far exceed” typical cost-effectiveness thresholds if priced at parity with approved therapy Radivaca edaravone from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508), according to a newly issued report from the Institute for Clinical and Economic Review. Although the report said a high price “could be considered” due to the unmet need in ALS, policy makers “should debate short-term pricing options including a far lower price close to the cost of production until the benefits of treatment can be adequately evaluated,” if FDA approves the therapy before a confirmatory study is completed. Amylyx’s AMX0035, a combination of sodium phenylbutrate and tauroursodeoxycholic acid, is under FDA review, with a PDUFA date of Sept. 29. Health Canada approved the drug on Monday with the brand name Albrioza.
A dataset centering on a Chinese study of third-generation EGFR inhibitor aumolertinib is the basis of the first global regulatory submission by EQRx Inc. (NASDAQ:EQRX). The submission, which has been accepted for review by the U.K.’s MHRA, is based on the Phase III AENEAS trial in which aumolertinib showed a survival benefit compared with Iressa gefitinib among patients with EGFR-mutated non-small cell lung cancer. Jiangsu Hansoh Pharmaceutical Group Co. Ltd. (HKEX:3692) markets aumolertinib as Ameile in China. EQRx holds the drug’s rights outside Greater China...