New Approvals

At its June 2024 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended ten new medicines for approval. Key among these is Balversa (erdafitinib), approved for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a type of bladder and urinary system cancer.

Another notable approval is Eurneffy (epinephrine), the first emergency treatment for allergic reactions administered as a nasal spray rather than an injection. Details on this approval can be found in the news announcement in the grid below.

mResvia, an mRNA vaccine targeting Respiratory Syncytial Virus (RSV), received a positive opinion for preventing lower respiratory tract disease in adults 60 years and older. This vaccine marks a significant milestone as the first mRNA vaccine approved for a pathogen other than SARS-CoV-2.

The committee also granted conditional marketing authorization for Ordspono* (odronextamab) for treating follicular lymphoma and diffuse large B-cell lymphoma, both of which are blood cancers affecting the immune system.

Piasky (crovalimab) received a positive opinion for treating paroxysmal nocturnal haemoglobinuria, a rare and potentially life-threatening genetic disorder.

In addition, Tauvid (flortaucipir (18F)) was approved for positron emission tomography (PET) imaging in adult patients with cognitive impairment being evaluated for Alzheimer's disease.

Winrevair* (sotatercept), supported through EMA's PRIME scheme, was approved to treat pulmonary arterial hypertension, a severe and life-threatening condition marked by high blood pressure in the lungs' arteries. More details can be found in the news announcement in the grid below.

Steqeyma (ustekinumab), a biosimilar medicine, received approval for treating several conditions including moderately-to-severely-active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis, and psoriatic arthritis.

Generic Medicines

The CHMP adopted positive opinions for two generic medicines: Enzalutamide Viatris (enzalutamide) for prostate cancer and Nilotinib Accord (nilotinib) for Philadelphia chromosome-positive chronic myelogenous leukemia.

Negative Opinions

Marketing authorizations were refused for Masitinib AB Science* (masitinib), intended for treating amyotrophic lateral sclerosis, and Syfovre (pegcetacoplan), for treating geographic atrophy secondary to age-related macular degeneration. More information on these refusals is available in the question-and-answer documents in the grid below.

Non-Renewal of Conditional Marketing Authorization

The committee recommended not renewing the conditional marketing authorization for Translarna* (ataluren), a treatment for non-sense mutation Duchenne muscular dystrophy. This opinion will be forwarded to the European Commission for a final, legally-binding decision applicable in all EU Member States. Additional information can be found in the public health communication in the grid below.

Extensions of Therapeutic Indications

The CHMP recommended extending the therapeutic indications for 11 medicines already authorized in the EU: Betmiga, Beyfortus, Cresemba, Imcivree*, Imfinzi, Infanrix hexa, Lynparza, Pegasys, Tepkinly*, Vabysmo, and Xalkori.

Withdrawal of Application

An application for an initial marketing authorization for Dabigatran etexilate Teva (dabigatran etexilate) intended for the prevention of venous thromboembolic events was withdrawn. A question-and-answer document on this withdrawal is available in the grid below.

Highlights

- Ten new medicines recommended for approval by EMA's CHMP in June 2024.

- Approval of Eurneffy, the first nasal spray for allergic reactions.

- mResvia, an mRNA vaccine for RSV, receives positive opinion.

- Conditional marketing authorization granted for Ordspono* and Piasky.

- Negative opinions for Masitinib AB Science* and Syfovre.

- Non-renewal of Translarna* marketing authorization.

- Extensions of therapeutic indications for 11 existing medicines.

- Withdrawal of Dabigatran etexilate Teva application.

- Conclusion of referrals for Havrix, Lorazepam Macure, and Ocaliva*.