The month of May could signal significant regulatory events for several biotech companies, following the FDA's approval of eight new drugs last May, leading to a total of 55 approvals for 2023. So far in 2024, 15 new drugs have been approved, raising hopes that this year could see even more approvals.
There are several biotech companies awaiting FDA decisions in May. Pfizer and Genmab are expecting to find out if their accelerated approval of Tivdak, an antibody-drug conjugate, will be fully approved on 9th May 2024. Currently used for treating adults with recurrent or metastatic cervical cancer, the drug demonstrated high efficacy in a clinical trial.
Meanwhile, Moderna anxiously awaits a verdict on its respiratory syncytial virus vaccine, mRNA-1345, due on 12th May. The vaccine aims to combat a virus that frequently leads to severe lower respiratory tract infections, causing thousands of deaths in older adults in the USA each year.
Dynavax Technologies hopes to receive FDA approval for an expanded use of its hepatitis B vaccine, Heplisav-B, for adults on hemodialysis. The decision is due to be announced on 13th May. The vaccine, which generated a substantial revenue increase in 2023, has demonstrated a significant seroprotection rate in clinical trials.
Ascendis Pharma seeks approval for its once-daily hormone replacement therapy, TransCon PTH. A decision is expected on 14th May. The drug, which is already approved in the EU, aims to treat adult patients with hypoparathyroidism. This constitutes Ascendis Pharma's second attempt to gain FDA approval for TransCon PTH after an unsuccessful first bid in May 2023.
Another company, Bristol Myers Squibb, is seeking FDA approval to extend the use of its drug Breyanzi for two more conditions, with FDA decisions due on 23rd and 31st May. Finally, an FDA panel is set to review Novo Nordisk's Awiqli, a once-weekly basal insulin analogue, for the treatment of diabetes in adults on 24th May.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) advised the endorsement of Awiqli last month as a treatment for adult diabetes. Prior to this, Awiqli had received approval in Canada in March of 2023.