FDA approves OTC oral contraceptive and Fast-Track STD treatment plus more news in this week’s Pharma Flash.
The FDA has granted approval to BioMarin’s Roctavian the first-ever gene therapy aimed at treating severe Hemophilia A in adults. Hemophilia A is a rare genetic bleeding disorder that occurs due to a mutation on the gene which produces factor VIII (FVIII), a protein that enables blood to clot. Roctavian is a one-time gene therapy product administered as a single dose by intravenous infusion. Roctavian consists of a viral vector carrying a gene for clotting Factor VIII. The gene is expressed in the liver to increase blood levels of FVIII and reduce the risk of uncontrolled bleeding.
GSK announced that the FDA granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG). The vaccine candidate is currently in an ongoing Phase II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age, considered at risk of gonorrhea.
The FDA has approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy. This marks the first daily oral contraceptive approved for use in the US without a prescription. This progestin-only oral contraceptive pill for consumers is available for purchase without a prescription at drug stores, convenience stores and grocery stores, and online. The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company.
Organon and Samsung Bioepis announced that HADLIMA™, a biosimilar referencing Humira (adalimumab), is now available to patients in the United States. HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care. HADLIMA is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Eli Lilly has chosen ABEC to construct a single-use biopharmaceutical manufacturing facility. This new facility is set to significantly expand Eli Lilly's production capacity and capabilities. The decision to utilize ABEC's expertise in single-use technology reflects the growing trend in the biopharmaceutical industry towards more flexible and cost-efficient manufacturing processes. The partnership aims to enhance Eli Lilly's ability to meet the increasing demand for biopharmaceutical products and advance the development of critical medications.