Drug News 16 Sept 2024, EMA, FDA approvals, new Phase 2 Phase 3 clinical data

European Medicine Agency (EMA)

The EMA’s Committee for Medicinal Products for Human Use (CHMP) will hold its monthly meeting from the 16th to 19th of September.

US Food and Drug Administration (FDA)

1. Ebglyss (lebrikizumab-lbkz, Eli Lilly) was approved by the FDA for the treatment of adults and children 12 years of age and older, weighing at least 40 kg, with moderate-to-severe atopic dermatitis (eczema). Eli Lilly press release.
2. Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs, Roche) was approved as the first PD-L1 inhibitor for subcutaneous (SC) administration. It will be available for all IV indications of Tecentriq that are approved for adults in the U.S. Roche press release.
3. Tremfya (guselkumab, Johnson & Johnson) was approved for the treatment of adults with moderately to severely active ulcerative colitis (UC). J&J 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 9th of September and 15th of September 2024:

1. AstraZeneca shared positive news from the Phase 3 study of datopotamab deruxtecan (Dato-DXd) in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). AstraZeneca press release.
2. Nice week for AstraZeneca, as they also reported positive data from the Phase 3b/4 trial of Enhertu (trastuzumab deruxtecan) in patients with HER2-positive metastatic breast cancer who have brain metastases. AstraZeneca press release.
3. Eli Lilly announced that two Phase 3 studies of efsitora alfa (efsitora) in patients with Type 1 and Type 2 diabetes met their primary endpoints. Eli Lilly press releases [1],[2].
4. GSK announced positive results from two Phase 3 trails of depemokimabin adults and adolescents with severe asthma with type 2 inflammation characterized by raised blood eosinophil count. GSK press release.
5. GSK also announced that a Phase 2 trial of its herpes simplex virus (HSV) vaccine, GSK3943104, did not meet its primary endpoint. This vaccine candidate will not advance to Phase 3 trials. GSK press release.
6. Gilead Sciences announced that the Phase 3 trial of lenacapavir for HIV prevention met its primary and secondary endpoints. As a result, Gilead has stopped the blinded portion of the trial and is qorking to bring lenacapavir to patients. Gilead press release.
7. Sanofi announced that two Phase 3 studies of Dupixent (dupilumab) in patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP) met their primary and key secondary endpoints. Sanofi press releases [1],[2].
8. Longboard Pharmaceuticals shared positive results from the Phase 2 extension trial evaluating bexicaserin (LP352) in participants ages 12-65 years old with developmental and epileptic encephalopathies (DEEs). Longboard press release.
9. Immunovant reported positive results from the Phase 2a trial of batoclimab in patients with Graves’ Disease. Immunovant press release.
10. PolTREG presented positive long-term data from Phase 1/2 trial of PTG-007 (Treg cell therapy) in patients with type 1 diabetes (T1D). PolTREG press release.
11. Viridian Therapeutics announced that the Phase 3 trial of veligrotug (VRDN-001) in patients with active thyroid eye disease (TED) met all primary and secondary endpoints. Viridian press release.
12. Innovent Biologics released positive data from two Phase 3 trials evaluating mazdutide in adults with type 2 diabetes and obesity. Innovent press release.
13. Eupraxia Pharmaceuticals shared positive data from the Phase 1b/2a trial of EP-104GI for the treatment for eosinophilic esophagitis (EoE). Eupraxia press release.
14. Neurocrine Biosciences announced that the Phase 2 clinical study of luvadaxistat (NBI-1065844) in patients with schizophrenia failed to meet its primary endpoint. Neurocrine press release.

Eye catching science

This is a new section that will report eye catching, potentially transormative, scientific findings.

This week, Ou et al and their team managed to make skin of a live rodent temporarly transsparent by adminstrating an tartrazine. I let you imagine the impacts of this finding. a long dream that may become true.

The article is published in Science issue of the Sept 12, 2024.

Zihao Ou et al., Achieving optical transparency in live animals with absorbing molecules.Science 385,eadm6869(2024).DOI:10.1126/science.adm6869