At its June 2024 meeting, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval.
The committee recommended the grant of registration for Balvers (erdafitinib), for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, bladder and urinary system cancer.
The CHMP adopted a positive opinion for Eurneffy (epinephrine), the first emergency treatment for allergic reactions that is given as a nasal spray rather than an injection. Please see the news release in the table below for more details.
mResvia (Respiratory syncytial virus (RSV) mRNA vaccine) received a positive opinion from the CHMP for the prevention of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus, a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults. It is the first mRNA vaccine targeting a pathogen other than SARS-CoV-2 to receive a positive opinion from the CHMP.
The Committee recommended the granting of conditional registration for Ordspono* (odronextamab), to treat follicular lymphoma and diffuse large B-cell lymphoma, two types of blood cancer that affect the immune system.
Sands (crovalimab) received a positive opinion from the CHMP for the treatment of paroxysmal nocturnal hemoglobinuria, a rare genetic disorder that causes the premature breakdown of red blood cells by the immune system and is potentially life-threatening.
The CHMP gave a positive opinion for Tauvid (flortaucipir (18F)), for positron emission tomography (PET) brain imaging in cognitively impaired adult patients being investigated for Alzheimer’s disease.
The CHMP recommended granting marketing authorization for Winrevair* (sotatercept), to treat adult patients with pulmonary arterial hypertension, a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries of the lungs. This medicine was supported through the EMA Priority Medicines (PRIME) programme, which provides early and extended scientific and regulatory support for promising medicines with the potential to address unmet medical needs. Please see the news release in the table below for more details.
The committee recommended the grant of registration for Steqeyma (ustekinumab), a biosimilar medicine for the treatment of adult patients with moderately to severely active Crohn’s disease, plaque psoriasis, pediatric plaque psoriasis and psoriatic arthritis.
The committee also adopted positive opinions on two generic medicines:
- Enzalutamide Viatris (enzalutamide) to treat prostate cancer.
- Nilotinib Accord (nilotinib) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia.
Negative opinions on two drugs
The CHMP recommended refusal of registration for Masitinib AB Science* (masitinib), a medicine used to treat amyotrophic lateral sclerosis, a rare disease of the nervous system leading to loss of muscle function and paralysis, and Syfovre (pegcetacoplan), for the treatment of geographic atrophy secondary to age-related macular degeneration, a progressive macular disease of the retina that causes gradual deterioration of vision, especially in the elderly.
For more information on these negative views, see the Q&A documents in the table below.
Failure to renew conditional registration
The committee recommended not to renew the conditional registration for Translarna* (ataluren), a drug to treat patients with a nonsense mutation in Duchenne muscular dystrophy, a genetic disorder characterized by progressive muscle wasting. This CHMP opinion will now be forwarded to the European Commission for a final legally binding decision valid in all European Union (EU) member states.
For more information on the non-renewal of this conditional registration, see the public health notice in the table below.
Recommendations to expand the therapeutic indication for 11 drugs
The committee recommended expanding the indication for 11 drugs that are already registered in the EU: Betmiga, Beyfortus, Cresemba, imcivree*, Imfinzi, Infanrix hexa, Lynparza, Pegasus, Tepkinly*, Vabysmo and Xalkori.
Application download
One application for first registration was withdrawn. Dabigatran etexilate Teva (dabigatran etexilate) was intended for the prevention of venous thromboembolic events.
A question and answer document on Dabigatran Teva withdrawal is available in the table below.
Conclusion of recommendations
The Commission has completed its review Havrix, a vaccine used to protect adults and children from hepatitis A virus infection, and recommended changes to the prescribing information to harmonize the way this medicinal product is used in the EU. A question and answer document is available in the table below.
The CHMP completed the review Lorazepam Macure, a medicine in the benzodiazepine class, following disagreement between EU member states over a request to update product information to include control of status epilepticus in adults, adolescents and children from one month of age. A question and answer document about this update is available in the table below.
EMA’s Committee for Medicinal Products for Human Use has concluded its review Ocaliva*medicine is used to treat adults with a rare liver disease known as primary biliary cholangitis and has recommended that the drug’s conditional marketing authorization be revoked because its benefits are no longer considered to outweigh its risks. For more information on the recommendation to withdraw this conditional marketing authorization, see the public health notice in the table below.
Another update
The CHMP issued a positive opinion on the update of the mRNA vaccine composition Comirnats to target the new SARS-CoV-2 JN.1 variant of the virus that causes COVID-19. The revision of this vaccine is in line with the recommendation issued by EMA’s Emergency Task Force to update the COVID-19 vaccines to target SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign.
Program and minutes
The program of the CHMP meeting in June 2024 is published on the EMA website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
The key figures from the June 2024 CHMP meeting are shown in the figure below.
*This product was designated as an orphan drug during its development. Orphan designations are reviewed at the time of approval by the EMA’s Committee for Orphan Medicinal Products (COMP) to determine whether the information available so far allows the orphan medicinal product to be maintained and to grant the medicinal product ten years of market exclusivity.