Drug news update 08 July 2024, approvals, clinical trials reported data

European Medicine Agency (EMA)

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will hold their monthly meeting this week from July 8th to July 11th.

US Food and Drug Administration (FDA)

Kisunla (donanemab-azbt, Eli Lilly) was approved by the FDA for the treatment of early symptomatic Alzheimer’s disease. Eli Lilly press release.

Sirturo (bedaquiline, Johnson and Johnson) was approved by the FDA in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. J&J press release.

Vabysmo (faricimab, Roche) single-dose prefilled syringe (PFS) was approved by the FDA for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Roche press release.

New data from clinical trials (Phase 2, Phase 3)

Here are the recent updates on Phase 2 and Phase 3 clinical trials with published data between the 1st and 7th of July 2024:

1. TRACON Pharmaceuticals announced the termination of the Phase 2 trial of envafolimab for the treatment of sarcoma, as the therapy is unlikely to show the level of efficacy required to support a biologics license application (BLA). TRACON press release.
2. Cartesian Therapeutics shared positive results from its Phase IIb trial of Descartes-08 (autologous mRNA CAR-T cells) in patients with generalized myasthenia gravis. Cartesian press release.
3. Johnson & Johnson reported positive data from the Phase 3 trial of Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed or lenalidomide-refractory multiple myeloma following one prior therapy line. J&J press release.
4. Alvotech has announced positive results from a confirmatory patient study assessing AVT03 (denosumab) as a proposed biosimilar to Amgen’s Prolia and Xgeva. Alvotech press release.
5. Annovis Bio announced new data from its Phase 3 study of buntanetap in patients with early Parkinson’s disease. Annovis press release.
6. Roche reported that its Phase 2/3 trial of tiragolumab along with Tecentriq (atezolizumab) and chemotherapy as first-line treatment for non-squamous non-small cell lung cancer (NSCLC) failed to meet primary endpoints. Roche press release.
7. IntelGenx announced preliminary results from its Phase 2a study of Montelukast VersaFilm (MTK) in adults with mild to moderate Alzheimer’s disease. IntelGenx press release.
8. Navidea Biopharma are dropping the rheumatoid arthritis (RA) programme after the Phase 3 trial evaluating Lymphoseek (Tc 99m tilmanocept) imaging to predict clinical response in individuals with RA who are beginning anti-tumor necrosis factor alpha (TNFα) therapy failed to meet its endpoints. Navidea press release.