European Medicine Agency (EMA)
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) held their monthly meeting this week from July 8th to July 11th. Here are the key takeaways:
- The PRAC recommended updating the product information for glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including a warning for patients to inform their doctor if they are scheduled to undergo surgery under anesthesia or deep sedation while taking these medicines. These measures aim to minimize the risk of aspiration and pneumonia aspiration reported in patients taking GLP-1 RAs who undergo surgery with general anesthesia or deep sedation.
- The PRAC agreed to inform healthcare professionals about the risk of anaphylactic reactions occurring months to years after initiating glatiramer acetate treatment (immunomodulator). If such a reaction occurs, treatment with glatiramer acetate must be discontinued. PRAC meeting highlights.
US Food and Drug Administration (FDA)
- The FDA rejected the Biologics License Application (BLA) for once-weekly basal insulin icodec (Novo Nordisk) for patients with Type 1 and Type 2 diabetes. The Complete Response Letter (CRL) cited issues related to the manufacturing process and the Type 1 diabetes indication. Novo Nordisk press release.
- Zoryve (roflumilast, Arcutis Biotherapeutics) was approved by the FDA for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Arcutis 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 8th and 14th of July 2024:
- Ideaya Biosciences reported positive interim data from a Phase 2 trial of IDE397 for the treatment of methylthioadenosine phosphorylase (MTAP) deletion urothelial and non-small cell lung cancer (NSCLC). Ideaya press release.
- Oxolife presented positive data from the Phase 2 trial of its non-hormonal fertility pill, OXO-001, in patients who underwent in vitro fertilization (IVF). Oxolife press release.
- AB Science announced numerical positive improvement from the Phase 2 trial of masitinib in hospitalized COVID-19 patients. However, the DSMB restricted the patients to include in the study and the study discontinued AB Science press release.
- HilleVax announced that the Phase 2b trial of HIL-214 (norovirus vaccine) in infants for the prevention of moderate or severe norovirus-related acute gastroenteritis failed to meet its primary or secondary endpoints. The company plans to halt further development of the vaccine for infants. HilleVax press release.
- uniQure announced positive news from the Phase 1/2 study of AMT-130 for the treatment of Huntington’s disease. uniQure press release.
- Kazia Therapeutics reported positive results from the Phase 2/3 trial of paxalisib for patients with glioblastoma. Kazia press release [pdf].
