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EMA

Serious allergic reactions: the first adrenaline nasal spray is arriving in Italy. The management of anaphylactic shock will change

by Dr. Michael Lee – Health Editor October 13, 2025

written by Dr. Michael Lee – Health Editor

First Adrenaline Nasal Spray for Anaphylaxis Approved in italy,Transforming Emergency Treatment

Rome,Italy – October 13,2025 – A new era in anaphylaxis management begins today with the approval of the first adrenaline nasal spray for emergency treatment of severe allergic reactions in Italy. The innovative delivery method promises faster administration and broader accessibility compared to traditional epinephrine auto-injectors, possibly saving lives and reducing the severity of anaphylactic episodes.

This progress marks a important shift in how anaphylactic shock – a potentially fatal,systemic allergic reaction – is addressed. Currently, treatment relies heavily on epinephrine auto-injectors, requiring patients (or bystanders) to administer a precise injection.The nasal spray offers a needle-free option, easing administration for individuals who may be anxious about injections, or whose reactions impair their ability to self-administer. Approximately 3-10% of the population experiences food allergies, and a significant percentage of those are at risk of anaphylaxis, making this advancement crucial for public health. The spray is expected to be available to patients via prescription in early 2026.

Anaphylaxis can be triggered by a wide range of allergens, including foods (peanuts, tree nuts, shellfish, milk, eggs), insect stings, medications, and latex. Symptoms escalate rapidly and can include difficulty breathing, swelling of the throat and tongue, dizziness, and a sudden drop in blood pressure. Prompt administration of epinephrine is critical to reversing these symptoms.

The approval follows accomplished clinical trials demonstrating the nasal spray’s efficacy and safety. Researchers found that the nasal spray delivered a comparable dose of epinephrine to auto-injectors, with similar absorption rates and clinical outcomes. Further details regarding the specific brand name and manufacturer will be released in the coming weeks by the Italian Medicines Agency (AIFA). This approval is anticipated to influence emergency protocols and patient education initiatives across Italy, emphasizing the importance of recognizing anaphylaxis symptoms and having readily available treatment options.

October 13, 2025 0 comments

Health

Tegomilfumarate Approval: New MS Treatment for Adults & Adolescents

by Dr. Michael Lee – Health Editor September 22, 2025

written by Dr. Michael Lee – Health Editor

New Treatment Option Approved for Relapsing-Remitting Multiple Sclerosis

On July ‍28,⁢ 2025, the European Commission (EC) approved ⁢tegomilfumarate for the treatment of⁤ relapsing-remitting multiple sclerosis⁢ (RRMS) in adults and adolescents aged 13 and older, ‌following a recommendation from the European Medicines ‍Agency (EMA). This adds a third fumarate-containing medication – alongside dimethyl ‌fumarate and diroximelfumarate -⁣ to the treatment options available⁢ in Germany for RRMS.

These ‌three medications share a‍ common mechanism,ultimately acting through the metabolite monomethyl fumarate,leading to a classification of bioequivalence. ⁣The EMA assessed tegomilfumarate’s similarity to dimethyl⁤ fumarate ⁤and granted approval via a “hybrid” pathway, referencing‍ the‌ established efficacy and safety data of dimethyl fumarate (Tecfidera®, approved in⁣ the ⁢EU ⁢since 2014).⁣ The ⁢EMA documentation‍ indicates a dosage ‌correlation: 174mg of tegomilfumarate is considered equivalent ‌to 120mg‌ of dimethyl fumarate, and 348mg ⁢of tegomilfumarate corresponds to 240mg of dimethyl fumarate.

While the precise way these fumarates⁢ work in MS remains under investigation, they are known to have immunomodulatory effects, increasing regulatory cells and decreasing pro-inflammatory and cytotoxic T cells.Research ‌also suggests a non-immunological effect within the ‌central nervous system, possibly through activation of the NRF2 pathway – a key regulator of antioxidant genes.

Tegomilfumarate (marketed as Riulvy®) is administered orally as a hard capsule twice daily,with ⁢a specific dosing schedule. Patients begin with a “start dose” ⁢of 2 x 174mg for the first 7 days, followed by a “conservation dose” of⁢ 2 x ⁢348mg from day 7 onwards. ‍ It is indeed⁤ possible that, similar to‍ experiences with dimethyl fumarate, clinicians may adopt a more gradual dose escalation in practice.

Due to the potential for ‍side effects and the complexity of MS treatment, initiation of tegomilfumarate therapy should be overseen by a physician experienced in managing multiple⁢ sclerosis.

The side effect profile of tegomilfumarate is expected to be similar to that of dimethyl fumarate, given ‌their shared ‍metabolic pathway.⁣ Common initial side effects include gastrointestinal issues like nausea, heartburn, abdominal pain, and diarrhea, as well as skin flushing. Existing warnings regarding leukopenia,progressive multifocal leukoencephalopathy (PML) risk,and⁣ pregnancy considerations,wich apply to dimethyl fumarate,also apply to tegomilfumarate.

Individuals ‍seeking further information on dimethyl fumarate and‍ diroximelfumarate can consult the current patient guides provided by the⁣ DMSG federal association and the disease-related competence-related multiple sclerosis (KKNMS).

September 22, 2025 0 comments

Health

Adapted Corona vaccine from BioNTech and Pfizer on the way » Leadersnet

by Chief editor of world-today-news.com September 23, 2024

written by Chief editor of world-today-news.com

| Editorial staff

|
22.09.2024

Approval by the European Commission is still pending, but a corresponding recommendation has now been received by the authority for review. The new vaccine is adapted to the KP.2 variant, which is particularly prevalent in early summer, but should also offer increased protection against the virus type that is currently prevalent.

Between May and July of this year, KP.2 was the predominant variant of the coronavirus; the seven-day incidence at that time was approximately between 200 and 300 cases per 100,000 inhabitants. KP.2 has since been replaced by KP.3.1.1 as the dominant variant in this country.

While BioNTech and Pfizer are certainly already working on a vaccine tailored to this purpose, the companies have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has now initially given a positive assessment for the marketing authorization of their product adapted from Omikron KP.2.

Approval is still pending

The CHMP’s recommendation was made on September 19 and is based “on non-clinical data and data from the manufacture of the vaccine adapted to Omikron KP.2, as well as data from clinical and practical use, which demonstrated the safety and efficacy of the previous COVID-19 vaccines from Pfizer and BioNTech.” Nevertheless, risks and side effects exist, which must be weighed up personally and possibly under medical advice.

It is now up to the European Commission (EC) to examine the recommendation. Once approved, the vaccine, called Comirnaty KP.2, will be available for use by people aged six months and over throughout the EU, “although availability will depend on demand from individual national governments and will vary according to national recommendations.”

“Significantly better immune response”

The non-clinical data underlying the CHMP’s recommendation confirm that the vaccine adapted to Omikron KP.2 provides “a significantly better immune response against several currently circulating Omikron JN.1 sublines” compared to the COVID-19 vaccine from BioNTech and Pfizer adapted to Omikron XBB.1.5. In addition to KP.2, LB.1 and KP.3, the currently rampant KP.3.1.1.1 variant is also mentioned in this context.

BioNTech is based in Mainz and generated sales of over 3.8 billion euros last year. The Comirnaty vaccines are based on the company’s own mRNA technology and were jointly developed with the US pharmaceutical company Pfizer.

The Ugur Sahin and Ozlem Tureci The company, founded in 1997, holds marketing authorization for Comirnaty and “variant-adapted vaccines in the United States, the European Union, the United Kingdom” and several other countries.

September 23, 2024 0 comments

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