First Nasal Adrenaline Spray Among EMA Approvals in June
EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.
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The European Medicines Agency (EMA) announced on June 28, 2024 that its Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for marketing approval in June. The approvals included the first nasal spray form of epinephrine, a biosimilar to treat autoimmune diseases, two generic medicines, and treatments for cancer.
Maybe most notable of the positive opinions is for Eurneffy (epinephrine), which is the first emergency treatment for allergic reactions administered through the nose. Epinephrine treats anaphylaxis, a severe allergic reaction that could result in death, and is traditionally administered via injection. According to EMA, a fear of needles may delay administration of the drug, making nasal delivery more appealing. Adrenaline delivered through a nasal spray is quickly absorbed through the nasal mucosa and distributed in the body.
Eurneffy was evaluated in 537 people aged 19–55 years of age in 14 clinical trials that compared Eurneffy with injectable adrenaline to review blood pressure, heart rate, absorption, and removal from the body. According to the EMA, results from adrenaline delivered through a nasal spray were comparable to intramuscular injected adrenaline. While there were no significant adverse reactions reported during studies, CHMP did recommend additional risk minimization to prevent potential inappropriate use of the product (1).
CHMP also recommended Winrevair (sotatercept) for the treatment of pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity in adults. The first activin signaling inhibitor therapy approved to treat PAH, according to EMA, sotatercept is administered every three weeks as a single injection. It is a copy of the activin receptor, ActRIIA, which is over-active in patients with PAH. In mimicking the ActRIIA receptor, sotatercept prevents activin from attaching to these receptors and activating them, therefore regulating the growth of new blood vessel cells in the lungs.
“Pulmonary arterial hypertension is a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs. Many patients experience breathing difficulty that limits their physical activity. Despite approved therapies, long-term prognosis remains poor: it is estimated that around 50% of patients will die within five to seven years after diagnosis,” EMA stated in a press release (2).
In addition to these positive opinions, CHMP also recommended the first messenger RNA (mRNA) vaccine targeting a different pathogen than SARS-CoV-2. mResvia (respiratory syncytial virus [RSV] mRNA vaccine) was approved to treat adults 60 years of age and older with lower respiratory tract disease and acute respiratory disease caused by RSV.
Treatments approved for cancers included Balversa (erdafitinib), to treat of adults with unresectable or metastatic urothelial carcinoma; Ordspono (odronextamab), which treats follicular lymphoma and diffuse large B-cell lymphoma; Enzalutamide Viatris (enzalutamide), to treat prostate cancer; and Nilotinib Accord (nilotinib) for the treatment of Philadelphia chromosome positive chronic myelogenous leukemia.
Other positive opinions were granted to treatments for paroxysmal nocturnal hemoglobinuria and a biosimilar to treat adults with moderately-to severely-active Crohn’s disease, plaque psoriasis, pediatric plaque psoriasis, and psoriatic arthritis (3).
References
- EMA. First Nasal Adrenaline Spray for Emergency Treatment Against Allergic Reactions. Press Release. June 28, 2024. https://www.ema.europa.eu/en/news/first-nasal-adrenaline-spray-emergency-treatment-against-allergic-reactions
- EMA. Positive CHMP Opinion on First-in-Class Medicine to Treat Pulmonary Arterial Hypertension. Press Release. June 28, 2024. https://www.ema.europa.eu/en/news/positive-chmp-opinion-first-class-medicine-treat-pulmonary-arterial-hypertension
- EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 June 2024. Press Release. June 28, 2024.
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