EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2019 meeting.
The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. AML is a rare type of cancer of the white blood cells (cells that fight infections). It affects approximately 1 in 10,000 people in the European Union. Xospata was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest.
Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus.
The CHMP recommended granting a marketing authorisation for Rhokiinsa (netarsudil) for the treatment of patients with glaucoma or ocular hypertension.
Senstend (lidocaine / prilocaine), which was evaluated in an informed consent application, received a positive opinion for the treatment of premature ejaculation in adult men. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.
The CHMP recommended granting marketing authorisations for three generic medicines: Arsenic trioxide Accord (arsenic trioxide), for the treatment of acute promyelocytic leukaemia; Bortezomib Fresenius Kabi (bortezomib), for the treatment of multiple myeloma and mantle cell lymphoma; and Ivozall (clofarabine), for the treatment of acute lymphoblastic leukaemia in paediatric patients.
The Committee recommended extensions of indication for Bavencio, Benlysta, Docetaxel Zentiva, Dupixent, Lucentis, Remsima, Taxotere and Trulicity.
The agenda of the September 2019 meeting is published on EMA's website. Minutes of the July 2019 CHMP meeting will be published in the coming weeks.
Key figures from the September 2019 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine's orphan status and granting the medicine ten years of market exclusivity.
| Name of medicine | Qtrilmet |
| INN | metformin hydrochloride / saxagliptin / dapagliflozin |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Treatment of type 2 diabetes mellitus |
| More information | Qtrilmet: Pending EC decision |
| Name of medicine | Rhokiinsa |
| INN | netarsudil |
| Marketing-authorisation applicant | Aerie Pharmaceuticals Ireland Ltd |
| Therapeutic indication | Treatment of patients with glaucoma or ocular hypertension |
| More information | Rhokiinsa: Pending EC decision |
| Name of medicine | Xospata |
| INN | gilteritinib |
| Marketing-authorisation applicant | Astellas Pharma Europe B.V. |
| Therapeutic indication | Treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation |
| More information | Xospata: Pending EC decision |
| Name of medicine | Senstend |
| INN | lidocaine / prilocaine |
| Marketing-authorisation applicant | Plethora Pharma Solutions Limited |
| Therapeutic indication | Treatment of premature ejaculation in adult men |
| More information | Senstend: Pending EC decision |
| Name of medicine | Arsenic trioxide Accord |
| International non-proprietary name (INN) | arsenic trioxide |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of acute promyelocytic leukaemia |
| More information | Arsenic trioxide Accord: Pending EC decision |
| Name of medicine | Bortezomib Fresenius Kabi |
| International non-proprietary name (INN) | bortezomib |
| Marketing-authorisation applicant | Fresenius Kabi Deutschland GmbH |
| Therapeutic indication | Treatment of multiple myeloma and mantle cell lymphoma |
| More information | Bortezomib Fresenius Kabi: Pending EC decision |
| Name of medicine | Ivozall |
| International non-proprietary name (INN) | clofarabine |
| Marketing-authorisation applicant | ORPHELIA Pharma SAS |
| Therapeutic indication | Treatment of acute lymphoblastic leukaemia in paediatric patients |
| More information | Ivozall: Pending EC decision |
| Name of medicine | Bavencio |
| INN | avelumab |
| Marketing-authorisation applicant | Merck Europe B.V. |
| More information | Bavencio: Pending EC decision |
| Name of medicine | Benlysta |
| INN | belimumab |
| Marketing-authorisation applicant | GlaxoSmithKline (Ireland) Limited |
| More information | Benlysta: Pending EC decision |
| Name of medicine | Docetaxel Zentiva |
| INN | docetaxel |
| Marketing-authorisation applicant | Zentiva, k.s. |
| More information | Docetaxel Zentiva (previously Docetaxel Winthrop): Pending EC decision |
| Name of medicine | Dupixent |
| INN | dupilumab |
| Marketing-authorisation applicant | Sanofi-Aventis Groupe |
| More information | Dupixent: Pending EC decision |
| Name of medicine | Lucentis |
| INN | ranibizumab |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| More information | Lucentis: Pending EC decision |
| Name of medicine | Remsima |
| INN | infliximab |
| Marketing-authorisation applicant | Celltrion Healthcare Hungary Kft. |
| More information | Remsima: Pending EC decision |
| Name of medicine | Taxotere |
| INN | docetaxel |
| Marketing-authorisation applicant | Aventis Pharma S.A. |
| More information | Taxotere: Pending EC decision |
| Name of medicine | Trulicity |
| INN | dulaglutide |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| More information | Trulicity: Pending EC decision |