European Medicine Agency
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will held its monthly meeting from December 9-12.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) held its monthly meeting from November 25-28. Here are the key takeaways:
The PRAC agreed to a direct healthcare professional communication (DHPC) informing of the risk of drug-induced liver injury (DILI) with Veoza (fezolinetant) and has recommended monitoring of liver function before and during treatment.
The PRAC concluded that the currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. PRAC meeting highlights.
US Food and Drug Administration (FDA)
- Bizengri (zenocutuzumab-zbco, Merus) received accelerated approval for the treatment of adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion. Merus press release.
- Imfinzi (durvalumab, AstraZeneca) was approved for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC). AstraZeneca press release.
- Yesintek (Ustekinumab-kfce, Biocon Biologics) was approved as a biosimilar to Stelara (Ustekinumab, Johnson & Johnson) for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Biocon 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 Nov25th and December 8th 2024:
- Eli Lilly shared positive results from the Phase 3b trial of Zepbound (tirzepatide) in adults living with obesity or overweight without diabetes. Eli Lilly press release.
- Roivant and Kinevant Sciences announced that the Phase 2 study of namilumab failed to show a treatment benefit in patients with chronic active pulmonary sarcoidosis. Roivant press release.
- BioAge Labs discontinued the Phase 2 study of azelaprag (as monotherapy and in combination with tirzepatide) for the treatment of obesity after liver transaminitis without clinically significant symptoms was observed in some subjects receiving azelaprag. BioAge Labs press release.
- Atea Pharmaceuticals announced that the Phase 2 study of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus (HCV) met its primary endpoints. Atea press release.
- Minghui Pharmaceutical reported positive results from its Phase 3 trial of MH004 (tofacitinib etocomil) ointment in adolescents (ages 12 years and older) and adults with mild to moderate atopic dermatitis (AD). Minghui Pharmaceutical press release.
- Cartesian Therapeutics announced shared positive data from the Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). Cartesian Therapeutics press release.
- Roche reported that the Phase 3 study evaluating tiragolumab combined with Tecentriq (atezolizumab) in patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC) did not meet its primary endpoint. Roche press release.
- Amgen reported positive data from the Phase 2 study of MariTide (maridebart cafraglutide) in people living with obesity or overweight without Type 2 diabetes. Amgen press release.
- Merck shared positive results from the Phase 3 study of Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH). Based on these results, an independent data monitoring committee recommended the early termination of the study. Merck press release.
- Biohaven reported that the Phase 3 trial of taldefgrobep alfa in patients with spinal muscle atrophy (SMA) did not meet its primary endpoint. Biohaven press release.
- Alector announced that Phase 2 trial of AL002 in individuals with early Alzheimer’s disease (AD) failed to meet its primary endpoint. Alector press release.
- Cassava Sciences announced that the the Phase 3 study of simufilam in mild-to-moderate AD did not meet its co-primary, secondary and exploratory biomarker endpoints. Cassava press release.
- Axsome Therapeutics announced that the Phase 3 study of AXS-12 (reboxetine) in patients with narcolepsy with cataplexy met the primary endpoint. Axsome press release.
- AstraZeneca reported positive results from its Phase 3 trial of Truqap combined with abiraterone and androgen deprivation therapy (ADT) in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC). AstraZeneca press release.
- PTC Therapeutics announced that the Phase 2 study of Utreloxastat in patients with amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint. PTC Therapeutics press release.
