Please find the approval for top 30 Pharma companies for the week ending 6-August-2023:
U.S. FDA Approves Merck’s ERVEBO® (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older
The U.S. Food and Drug Administration (FDA) has approved an expanded indication for ERVEBO, which is now indicated for the prevention of disease brought on by the Zaire ebolavirus in people 12 months of age and older, according to Merck (NYSE: MRK), also known as MSD outside of the United States and Canada. The vaccination was previously authorised for use in anyone aged 18 and over. The duration of the protection offered by ERVEBO is uncertain, and it does not offer protection against other Ebolavirus or Marburgvirus species. It is unknown whether the vaccination works well when given along with immune globulin (IG), blood or plasma transfusions, antiviral drugs, or both. For those who have experienced a history of a severe allergic reaction (such as anaphylaxis), ERVEBO includes a contraindication.
Iveric Bio, an Astellas Company, Receives U.S. FDA Approval for IZERVAY™, a New Treatment for Geographic Atrophy
FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression
Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen (Nasdaq: BIIB) announced that the US Food and Drug Administration has approved ZURZUVAETM (zuranolone) 50 mg for people with postpartum depression (PPD). ZURZUVAE is the first and only oral, once daily, 14-day medication that can significantly lessen depressed symptoms in PPD-affected women. ZURZUVAE is projected to go on sale and be made available to consumers in the fourth quarter of 2023.
The FDA also released a Complete Response Letter (CRL) for the New Drug Application (NDA) for the use of zuranolone in the treatment of adults with major depressive disorder (MDD). In order to support the approval of zuranolone for the treatment of MDD, the CRL noted that the application lacked sufficient evidence of efficacy and that one or more additional studies would be required. Sage and Biogen are considering the comments and possible actions now.
