The Food and Drug Administration (FDA) ended 2024 with four notable approvals, including three new medicines developed by Vertex Pharmaceuticals, Novo Nordisk, and Bristol Myers Squibb for cystic fibrosis, hemophilia, and cancer, respectively. The approvals mark a record year for the agency, clearing 50 novel medicines, surpassing the 55 in 2023.
Vertex’s Alyftrek is the first of these new medicines to gain approval, extending its dominance in the lung disease cystic fibrosis market. Prior to Alyftrek’s approval, Vertex had brought four cystic fibrosis medicines to market, generating nearly $10 billion in sales. Alyftrek, a three-drug combination, uses a compound called tezacaftor as its chemical backbone and has been shown to be statistically “non-inferior” to Trikafta on lung function and better at lowering chloride levels.
Novo Nordisk’s Alhemo was also approved for people aged 12 and above with hemophilia A or B, providing an alternative to Pfizer’s Hympavzi. Bristol Myers Squibb’s Opdivo Qvantig was approved as a cancer immunotherapy administered via under-the-skin injection, offering faster delivery times compared to traditional infusion methods.
Finally, Lilly’s Zepbound was granted clearance for obstructive sleep apnea treatment in adults with moderate-to-severe obesity and sleep apnea. This marks the first prescription medicine approval for this condition, adding another indication for incretin medicines, which have also been shown to be beneficial for diabetes, heart failure, kidney disease, and liver disorder.
All four approvals demonstrate significant advancements in medical treatments, with Alyftrek and Opdivo Qvantig offering improved delivery times and better efficacy. The FDA’s record-breaking year highlights the agency’s commitment to accelerating innovative medicines to patients.
Source: https://www.biopharmadive.com/news/fda-drug-approvals-end-2024-alyftrek-opdivo-qvantig-alhemo/736282