European Medicine Agency (EMA)
The next CHPM meeting is planned on the of week of 22 Jan 2024.
If you are interested about the summary of previous CHMP meetings, send an email to [email protected] with in the title: CHMP, we will take care of it.
US Food and Drug Administration (FDA)
No new drugs were approved last week by the FDA. Nothing since the approval of Zelsuvmi (berdazimer) in the treatment of molluscum contagiosum on 05 Jan 2024.
Safety Surveillance PRAC and FDA
The PRAC did meet last week. The main conclusions were:
- Recommendation of additional safety measures for the treatment of male patients with drugs based on Valproate (teratogenicity risk). The PRAC continues to put pressure on this compound.
- More interesting: the PRAC is evaluating a signal of secondary malignancies when using several CAR T-cell medicines. Developing secondary malignancy was considered as an “important potential risk”, now the PRAC is reviewing the 23 cases reported through Eudravigilance. Please note that “important potential risk” is a regulatory definition of an adverse event being evaluated.
- The PRAC reviewed the Post Marketing Safety Studies (PASS) that were imposed during the marketing authorisation for the following compounds:
- Alemtuzumab – LEMTRADA
- Axicabtagene ciloleucel – YESCARTA
The FDA published on 11 Jan 2024 recommendations regarding the risk of suicide when using GLP-1 agonists such as Semaglutide. the FDA does not identify a causal risk however recommends to patients several monitoring measures of suiciadal risks. For more information, check the FDA update
New data from phase 2 and phase 3 studies
Here are the recent updates on Phase 2 and Phase 3 clinical trials with published data between January 8 and January 14, 2024:
- Elinzanetant (Bayer), a menopausal relief drug: Bayer reported success in two late-stage trials for its menopausal relief drug and initiates a phase 2 trial in sleep disturbances associated with menopause (SDM). The drug was shown to ease hot flashes and improve sleep. More data on the press release.
- Lutikizumab for Hidradenitis Suppurativa (Abbvie): the compounds showed positive data in adults with moderate to severe hidradenitis suppurativa. The primary endpoint, HiSCR 50 at week 16, was met by patients who achieved at least a 50% reduction in the total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline. The company moves the compound to Phase 3.
- AR-15512 (Alcon): showed positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating AR-15512 for the signs and symptoms of dry eye disease (DED). The primary endpoint was met, showing a significant increase in unanesthetized Schirmer’s score at Day 14. See more in the press release.
- CV0701 COVID-19 Vaccine (CureVac): Phase II trial data for the bivalent vaccine CV0701, tested at low, medium, and high doses, demonstrated post-booster neutralising antibody titres significantly higher than pre-booster levels on day 29. This vaccine was evaluated against the Omicron BA.4-5 variant and the original SARS-CoV-2 strain. The press release is dated on the 05 Jan 2024 but was largely distributed only on the 08 Jan.
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