EMA CHMP Meeting: 5 New Medicines, 13 Indication Extensions Recommended
Summary
The EMA's CHMP recommended five new medicines for approval and extensions of therapeutic indications for 13 existing medicines at its March 2026 meeting. The committee also confirmed a refusal for a marketing authorisation change and noted the withdrawal of an application for a new Alzheimer's treatment.
What changed
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for five new medicines, including conditional marketing authorisations for Adstiladrin and Imdylltra, and marketing authorisations under exceptional circumstances for Joenja and Zepzelca. Additionally, 13 existing medicines received recommendations for extensions of their therapeutic indications. The CHMP also confirmed its refusal to modify the marketing authorisation for Hetlioz and noted the withdrawal of the application for Blarcamesine Anavex for Alzheimer's disease.
These recommendations signify significant advancements in available treatments for various conditions, including bladder cancer, lung cancer, rare immune system disorders, and oedema. Pharmaceutical companies and regulatory affairs professionals should note the specific indications and authorisation types (conditional, exceptional circumstances, PUMA) for these new medicines, as well as the outcomes for the extended indications and the refused/withdrawn applications. While no immediate compliance actions are required for regulated entities based on this meeting highlight, it signals upcoming product approvals and potential market entries.
Source document (simplified)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026
27 March 2026
Five new medicines recommended for approval; another 13 medicines recommended for extension of their therapeutic indications News Human Medicines
Five new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2026 meeting.
The committee recommended granting a conditional marketing authorisation for Adstiladrin (nadofaragene firadenovec), for the treatment of adult patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours.
The CHMP recommended granting a marketing authorisation for Imdylltra (tarlatamab), a new treatment for relapsed extensive-stage small cell lung cancer which addresses an unmet medical need in adults with poor prognosis and limited treatment options. See more details in the news announcement in the grid below.
Joenja (leniolisib) received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more. APDS is a rare, inherited progressive and potentially life-threatening condition of the immune system. The incidence rate of this disease around the world is estimated to be 1 to 2 per million people.
A positive opinion was adopted for Zepzelca (lurbinectedin) for the maintenance treatment in patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy.
The CHMP recommended granting a paediatric-use marketing authorisation (PUMA) for Bopediat (furosemide) for the treatment of oedema (swelling caused by excess fluid) of cardiac or renal origin, oedema of hepatic origin and hypertension in children from birth to under 18 years of age with chronic kidney disease. This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product and in part on new data.
Recommendations on extensions of therapeutic indication for 13 medicines
The committee recommended extensions of indication for 13 medicines that are already authorised in the EU: Besponsa, Capvaxive, Feraccru, Hetronifly (two extensions of therapeutic indication), Hympavzi, Imcivree, Lojuxta, Mekinist (two extensions of therapeutic indication), mResvia, Namuscla, Retsevmo, Sotyktu and Tafinlar (two extensions of therapeutic indication).
Outcome of re-examination
After re-examining its initial opinion, the committee confirmed its recommendation to refuse a change to the marketing authorisation for Hetlioz (tasimelteon). The change concerned an extension of indication to include the treatment of nighttime sleep disturbance in adults and children aged 3 to 15 years with Smith-Magenis syndrome, a rare hereditary disorder characterised by developmental delay, behavioural problems and sleep disturbance.
The CHMP issued this opinion during an extraordinary meeting on 16 March 2026.
Withdrawal of application
An application for an initial marketing authorisation was withdrawn. Blarcamesine Anavex (blarcamesine) was developed for the treatment of Alzheimer’s disease and dementia.
A question-and-answer document on the withdrawal of this application is available in the grid below.
Conclusion of referral
The committee finalised its review of Tecovirimat SIGA (tecovirimat), an antiviral medicine that was authorised to treat smallpox, mpox and cowpox, three infections caused by viruses belonging to the same family (orthopoxviruses). The CHMP recommended that Tecovirimat SIGA should no longer be used for the treatment of mpox. The review of Tecovirimat SIGA was initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
For more information, see the public health communication in the grid below.
Other updates
The committee adopted a new route of administration, subcutaneous, together with a new pharmaceutical form and a new strength for Sarclisa, a cancer medicine used to treat adults with multiple myeloma.
The committee adopted a reflection paper on a tailored clinical approach in biosimilar development, which aims to reduce the amount of clinical data required for the development and approval of certain biosimilar medicines in the EU. A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
Agenda and minutes
The agenda of the March 2026 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
Key figures from the March 2026 CHMP meeting are represented in the graphic below.
CHMP statistics: Text version
March 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
- 5 positive opinions on new medicines: 1 new non-orphan medicine, 3 orphan medicines, and 1 generic, hybrid or informed consent medicine. Total in 2026: 23
- 0 negative opinions on new medicines. Total in 2026: 2
- 16 positive opinions on extensions of therapeutic indication. Total in 2026: 31
- 1 withdrawn applications for new medicines. Total in 2026: 2
Positive recommendations on new medicines
Adstiladrin
INN nadofaragene firadenovec
Marketing authorisation applicant Ferring Pharmaceuticals A/S
Therapeutic indication Treatment of adult patients with high-grade (HG), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
More information Adstiladrin : pending EC decision
Imdylltra
INN tarlatamab
Marketing authorisation applicant Amgen Europe B.V
Therapeutic indication Treatment of extensive-stage small cell lung cancer.
More information Imdylltra : pending EC decision
Orphan designation This medicine was designated an orphan medicine.
News New treatment for relapsed extensive-stage small cell lung cancer
Joenja
INN leniolisib
Marketing authorisation applicant Pharming Technologies B.V.
Therapeutic indication Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS).
More information Joenja : pending EC decision
Orphan designation This medicine was designated an orphan medicine.
Zepzelca
INN lurbinectedin
Marketing authorisation applicant Pharma Mar S.A.
Therapeutic indication Maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
More information Zepzelca : pending EC decision
Orphan designation This medicine was designated an orphan medicine.
Positive recommendations on new hybrid medicines
Bopediat
INN furosemide
Marketing authorisation holder Proveca Pharma Limited
Therapeutic indication Treatment of all conditions requiring diuresis due to mechanical obstruction or venous insufficiency.
More information Bopediat : pending EC decision
Positive recommendations on extensions of therapeutic indications
Besponsa
INN inotuzumab ozogamicin
Marketing authorisation holder Pfizer Europe MA EEIG
More information Besponsa : pending EC decision
Capvaxive
INN pneumococcal polysaccharide conjugate vaccine (21-valent)
Marketing authorisation holder Merck Sharp & Dohme B.V.
More information Capvaxive : pending EC decision
Feraccru
INN ferric maltol
Marketing authorisation holder Norgine B.V.
More information Feraccru : pending EC decision
Hetronifly
INN serplulimab
Marketing authorisation holder Accord Healthcare S.L.U.
More information Hetronifly: pending EC decision (EMA/VR/0000284402)
Hetronifly: pending EC decision (EMA/VR/0000282407)
Hympavzi
INN marstacimab
Marketing authorisation holder Pfizer Europe MA EEIG
More information Hympavzi : pending EC decision
Imcivree
INN setmelanotide
Marketing authorisation holder Rhythm Pharmaceuticals Netherlands B.V.
More information Imcivree : pending EC decision
Lojuxta
INN lomitapide
Marketing authorisation holder Chiesi Farmaceutici SpA
More information Lojuxta : pending EC decision
Mekinist
INN trametinib
Marketing authorisation holder Novartis Europharm Limited
More information Mekinist : pending EC decision (EMAVR0000271728)
Mekinist : pending EC decision (EMAVR0000278305)
Mresvia
INN respiratory syncytial virus mRNA vaccine (nucleoside modified)
Marketing authorisation holder Moderna Biotech Spain, S.L.
More information Mresvia : pending EC decision
Namuscla
INN mexiletine hcl
Marketing authorisation holder Lupin Europe GmbH
More information Namuscla : pending EC decision
Retsevmo
INN selpercatinib
Marketing authorisation holder Eli Lilly Nederland B.V.
More information Retsevmo : pending EC decision
Sotyktu
INN seucravacitinib
Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG
More information Sotyktu : pending EC decision
Tafinlar
INN dabrafenib
Marketing authorisation holder Novartis Europharm Limited
More information Tafinlar : pending EC decision (EMAVR0000271728)
Tafinlar : pending EC decision (EMAVR0000278305)
Outcome of re-examination
Hetlioz
INN tasimelteon
Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V.
More information Hetlioz
Withdrawal of application
Blarcamesine Anavex
INN blarcamesine
Marketing authorisation applicant Anavex Germany GmbH
Therapeutic indication Treatment of Alzheimer’s disease and dementia.
More information Blarcamesine Anavex
Referral procedures
Tecovirimat SIGA
INN tecovirimat
More information Tecovirimat SIGA
Other updates
Sarclisa
INN isatuximab
Marketing authorisation holder Sanofi Winthrop Industrie
More information Sarclisa : pending EC decision
Reflection paper on a tailored clinical approach in biosimilar development
Adopted Reference Number: EMA/CHMP/BMWP/60916/2025 English (EN) (327.07 KB - PDF)
First published:
27/03/2026
View Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.
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- Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2026
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- New treatment for relapsed extensive-stage small cell lung cancer
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