EMA CHMP Agenda: Hetlioz for Smith-Magenis Syndrome

EMA CHMP Agendas & Minutes

Published March 16th, 2026

Detected March 16th, 2026

Summary

The European Medicines Agency (EMA) has published the agenda for an extraordinary CHMP meeting on March 16, 2026. The agenda includes discussions on the re-examination procedure for Hetlioz (Tasimelteon) for Smith-Magenis Syndrome, involving oral explanations and variations to marketing authorisations.

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This document is an agenda for an extraordinary meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) scheduled for March 16, 2026. The primary focus is the re-examination procedure for Hetlioz (Tasimelteon), a drug indicated for Smith-Magenis Syndrome. The agenda details oral explanations and potential variations to the marketing authorisation, referencing specific procedure numbers and previous opinions.

This agenda serves as a working document for CHMP members and outlines the topics to be discussed. While it indicates procedures related to Hetlioz, it does not impose new obligations or deadlines on regulated entities. Information deemed commercially confidential or sensitive is not disclosed. Further details will be published in CHMP meeting highlights upon finalisation of procedures.

Source document (simplified)

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 16 March 2026 Human Medicines Division Agenda for the extraordinary meeting on 16 March 2026 Chair: Bruno Sepodes – Vice-Chair: Outi Mäki-Ikola 16 March 2026, 14:00-17:00, virtual meeting Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006).

Page 2/4 Table of contents 1. Introduction 3 1.1. Welcome and declarations of interest of members, alternates and experts ............ 3 1.2. Adoption of agenda ................................................................................................ 3 2. Oral Explanations 3 2.1. Re-examination procedure oral explanations ......................................................... 3 2.1.1. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/X/0039 ........................................... 3 2.1.2. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/II/0040 .......................................... 3 3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 4 3.1. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 ......................................... 4 3.1.1. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/X/0039 ........................................... 4 4. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/20084 4.1. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 ...................................... 4 4.1.1. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/II/0040 .......................................... 4

Page 3/4 1. Introduction 1.1. Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the CHMP extraordinary plenary session to be held 16 March 2026. See 16 March 2026 CHMP minutes (to be published post March 2026 CHMP meeting). 1.2. Adoption of agenda CHMP agenda for extraordinary CHMP meeting to be held on 16 March 2026 2. Oral Explanations 2.1. Re-examination procedure oral explanations 2.1.1. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/X/0039 Vanda Pharmaceuticals Netherlands B.V. Scope: Oral explanation Action: Oral explanation to be held on 16 March 2026 at 14:15 Opinion on 11.12.2025. List of Outstanding Issues adopted on 18.09.2025, 24.07.2025. List of Questions adopted on 27.02.2025. See 3.1 2.1.2. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/II/0040 Vanda Pharmaceuticals Netherlands B.V. Scope: Oral explanation Action: Oral explanation to be held on 16 March 2026 at 14:15 Opinion adopted on 13.11.2025. Request for Supplementary Information adopted on 25.04.2025, 30.01.2025. See 4.1

Page 4/4 3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 3.1. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 3.1.1. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/X/0039 Vanda Pharmaceuticals Netherlands B.V. Scope: “Extension application to introduce a new pharmaceutical form associated with new strength (4 mg/ml oral solution). The new formulation is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in paediatric patients 3 to 15 years of age. The RMP (version 5.0) is updated in accordance.” Action: For adoption Opinion adopted on 11.12.2025. List of Outstanding Issues adopted on 18.09.2025, 24.07.2025. List of Questions adopted on 27.02.2025. See 2.1 4. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008 4.1. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 4.1.1. Hetlioz - Tasimelteon - Orphan - EMEA/H/C/003870/II/0040 Vanda Pharmaceuticals Netherlands B.V. Scope: “Extension of indication to include the treatment of nighttime sleep disturbances in adults with Smith Magenis Syndrome (SMS) for HETLIOZ, based on results from study VP- VEC-162-2401. This is a double-blind, randomized, two-period crossover study evaluating the effects of tasimelteon vs. placebo on sleep disturbances of individuals with Smith- Magenis Syndrome (SMS). As a consequence, sections 4.1, 4.5, 5.1, 5.2 and 5.3 of the SmPC are updated. The Labelling and Package Leaflet are updated in accordance. The RMP version 5.0 has also been submitted. Furthermore, the PI is brought in line with the latest QRD template version 10.4. As part of the application, the MAH is requesting a 1-year extension of the market protection.”, Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004) Action: For adoption Opinion adopted on 13.11.2025. Request for Supplementary Information adopted on 25.04.2025, 30.01.2025. See 2.1