EMA Marketing Authorization of New Drugs in January 2025

Shots:

The EMA’s CHMP has granted positive opinions to 5 Biologics in January 2025, leading to treatments for patients and advances in the healthcare industry

The major highlighted drugs were Merck’s Capvaxive to treat Pneumococcal Disease

PharmaShots has compiled a list of 4 drugs that have been granted positive opinions and approvals by the EMA’s CHMP & EC, respectively

Company: InflaRx

Product: Gohibic

Active Ingredient: Vilobelimab

Disease: Acute Respiratory Distress Syndrome

Date: Jan 15, 2025

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The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO)

Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with a 23.9% relative reduction in 28-day all-cause mortality. The data was published in The Lancet Respiratory Medicine

The marketing authorization for GOHIBIC is valid in all 27 EU member states, Iceland, Liechtenstein, and Norway. InflaRx is exploring commercial partnerships in the EU

Company: Bavarian Nordic

Product: Vimkunya

Active Ingredient: CHIKV VLP vaccine

Disease: Chikungunya

Date: Jan 30, 2025

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The CHMP has recommended Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.), with the EC’s decision & launch expected in H1’25 for the EU, Iceland, Liechtenstein, & Norway

Opinion was based on 2 P-III studies showing a rapid immune response in 1wk. with ~97.8% of participants (n=3,500) developing neutralizing antibodies by day 21

Following the positive CHMP opinion, the company will submit an MAA to the UK MHRA under the IRP, with potential UK approval in H1’25. Vaccine is also under priority review by the US FDA (PDUFA: Feb 14, 2025)

Company: Daiichi Sankyo and AstraZeneca

Product: Datroway

Active Ingredient: Datopotamab Deruxtecan-dlnk

Disease: Unresectable or Metastatic HR+/HER2- Breast Cancer

Date: Jan 30, 2025

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The CHMP has recommended Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts receiving endocrine-based therapy & CT. Ongoing regulatory review in China & other regions

Opinion was supported by a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin, capecitabine, vinorelbine or gemcitabine) in HR+/HER2- breast cancer pts (n=732)

Study showed improved PFS of 37%, mPFS (6.9 vs 4.9mos.), cORR (36% vs 23%) with CR (0.5% vs 0%) & PR (36% vs 23%), plus mDoR (6.7 vs 5.7mos). Data was published in JCO

Company: Merck

Product: Capvaxive

Active Ingredient: Pneumococcal 21-valent Conjugate Vaccine

Disease: Pneumococcal Disease

Date: Jan 30, 2025

Shots:

The CHMP has recommended Capvaxive for active immunization against invasive disease & pneumonia caused by Streptococcus pneumoniae in adults (≥18yrs.), with the EC’s decision expected in Q2’25 for EU, Iceland, Liechtenstein and Norway. Ongoing regulatory review in Japan, plus multiple filings are underway

Opinion was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20 in pneumococcal vaccine-naïve adults (≥18yrs.), plus data from various P-III trials (STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7, & STRIDE-10) assessing it in both vaccine-naïve & vaccinated adults

Capvaxive (single dose) targets Streptococcus pneumoniae serotypes against IPD in adults, incl. 8 unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, 35B)

Note: The following drugs have also been recommended for approval, however, no PR was available: