Verdict for Biogen’s Long-Awaited Alzheimer’s Drug Is Finally Here
The USFDA finally gave approval to eagerly-anticipated Biogen’s Drug Aducanumab for the treatment of Alzheimer’s disease under the accelerated approval pathway. The drug, marketed under the name Aduhelm, is the first that treats an underlying cause of the disease.
Biogen and its collaborator Eisai had abandoned the drug in March 2019 after the drug failed to meet endpoints. However, after a few months, the company again got back in full swing with its drug with a full analysis of one of the trials, the Phase III EMERGE study, demonstrating that the drug had hit the primary endpoint at the highest dose, and managed to attain a significant decrease in clinical decline
However, a lot of controversies surround the approval as many researchers and physicians believe that the data presented do not provide substantial evidence of the drug’s efficacy and its risk-benefit profile while many others herald the approval as historic and hopeful.
FDA Gives Thumbs-Up to Novo Nordisk’s Weight Management Drug
The U.S. FDA has finally approved Novo Nordisk’s Wegovy for chronic weight management. The therapy is approved for weight control in people living with obesity.
Wegovy is a once-weekly semaglutide 2.4 mg self-injection. It is the first and only once-weekly GLP-1 receptor agonist approved so far to control weight. The drug is already available in the market under the brand name Ozempic, however, at a higher dose and is used to treat type 2 diabetes.
The company now plans to launch the drug in the US this month while its applications are still under review in the European Union and other countries. Talking about its pricing, Novo plans to tag it in similar lines as it already markets an injectable drug for weight loss, Saxenda, however, has not yet disclosed the exact price.
FDA Lifts Clinical Holds from Bluebird’s Gene Therapy
The USFDA has lifted the clinical hold put on Bluebird Bio’s the company’s gene therapies Zynteglo and LentiGlobin. Earlier this year in January, the FDA had put a pause on the company’s phase 1/2 Sickle cell disease (SCD) trial for LentiGlobin and two-phase III studies investigating Zynteglo in transfusion-dependent Beta-Thalassemia (TDT).
LentiGlobin is an investigational treatment under study as a potential treatment for SCD. bluebird bio’s clinical development program for LentiGlobin for SCD includes the completed Phase 1/2 HGB-205 study, the ongoing Phase 1/2 HGB-206 study, and the ongoing Phase 3 HGB-210 study.
Zynteglo (Betibeglogene autotemcel (beti-cel)) is a one-time gene therapy that adds functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic (blood) stem cells (HSCs).