Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
News
Human
Medicines
Four new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults, a skin disease causing red, scaly patches.
The committee adopted positive opinions for three generic medicines:
- Dapagliflozin Viatris (dapagliflozin) for the treatment of type 2 diabetes mellitus, heart failure and chronic kidney disease.
- Sitagliptin/Metformin hydrochloride Sun (sitagliptin/metformin hydrochloride) for the treatment of type 2 diabetes mellitus.
- Tolvaptan Accord (tolvaptan) to treat adults with low blood sodium levels caused by the syndrome of inappropriate antidiuretic hormone secretion.
Negative opinion for one new medicine
The CHMP recommended the refusal of a marketing authorisation for Sohonos* (palovarotene) for the treatment of fibrodysplasia ossificans progressiva, a rare genetic disease that causes extra bone to form in places outside the skeleton, such as in joints, muscles, tendons and ligaments, leading to progressively decreasing mobility and other severe impairments. For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for seven medicines
The committee recommended seven extensions of indication for medicines that are already authorised in the European Union (EU): Byfavo, Dupixent, Nubeqa, Reblozyl, Trecondi, Trulicity and Wakix.
Withdrawals of applications
The application for marketing authorisation for Garsun* was withdrawn. This medicine was intended for the treatment of severe malaria caused by the parasite Plasmodium falciparum in patients in the EU.
The application to extend the therapeutic indication of Imbruvica in combination with bendamustine and rituximab in patients with previously untreated mantle cell lymphoma, a cancer of a type of white blood cell, was withdrawn.
Question-and-answer documents on the withdrawals are available in the grid below.
Start of referral
The committee started a review of Adakveo, a medicine for preventing painful crises in patients with sickle cell disease, following preliminary results from a study that raise questions over the effectiveness of the medicine. The CHMP will assess the impact of these findings on the balance of benefits and risks of Adakveo and possible impact on the marketing authorisation. A public health communication on this referral is available in the grid below.
Conclusion of referral
The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) and issued a revised opinion to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. A public health communication on this referral procedure is available in the grid below.
COVID-19 update
The committee recommended converting the conditional marketing authorisation of the COVID-19 treatment Paxlovid to a standard marketing authorisation.
Agenda and minutes
The agenda of the January 2023 CHMP meeting is published on EMA's website. Minutes of the December 2022 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the January 2023 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.
Positive recommendation on new medicine
| Name of medicine | Sotyktu |
| International non-proprietary name (INN) | deucravacitinib |
| Marketing-authorisation applicant | Bristol-Myers Squibb Pharma EEIG |
| Therapeutic indication | Treatment of moderate to severe plaque psoriasis in adults |
| More information | Sotyktu: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Dapagliflozin Viatris |
| INN | dapagliflozin |
| Marketing-authorisation applicant | Viatris Limited |
| Therapeutic indication | Treatment of type 2 diabetes mellitus, heart failure and chronic kidney disease |
| More information | Dapagliflozin Viatris: Pending EC decision |
| Name of medicine | Sitagliptin / Metformin hydrochloride Sun |
| INN | sitagliptin / metformin hydrochloride |
| Marketing-authorisation applicant | Sun Pharmaceutical Industries Europe B.V. |
| Therapeutic indication | Treatment of type 2 diabetes mellitus |
| More information | Sitagliptin / Metformin hydrochloride Sun: Pending EC decision |
| Name of medicine | Tolvaptan Accord |
| INN | tolvaptan |
| Marketing-authorisation holder | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of low blood sodium levels in adults secondary to the syndrome of inappropriate antidiuretic hormone secretion |
| More information | Tolvaptan Accord: Pending EC decision |
Negative recommendation on new medicine
| Name of medicine | Sohonos |
| INN | palovarotene |
| Marketing-authorisation holder | Ipsen Pharma |
| Therapeutic indication | Treatment of fibrodysplasia ossificans progressiva |
| More information | Sohonos: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Byfavo |
| INN | remimazolam |
| Marketing-authorisation holder | PAION Deutschland GmbH |
| More information | Byfavo: Pending EC decision |
| Name of medicine | Dupixent |
| INN | dupilumab |
| Marketing-authorisation holder | Sanofi Winthrop Industrie |
| More information | Dupixent: Pending EC decision |
| Name of medicine | Nubeqa |
| INN | darolutamide |
| Marketing-authorisation holder | Bayer AG |
| More information | Nubeqa: Pending EC decision |
| Name of medicine | Reblozyl |
| INN | luspatercept |
| Marketing-authorisation holder | Bristol Myers Squibb Pharma EEIG |
| More information | Reblozyl: Pending EC decision |
| Name of medicine | Trecondi |
| INN | treosulfan |
| Marketing-authorisation holder | medac Gesellschaft für klinische Spezialpräparate mbH |
| More information | Trecondi: Pending EC decision |
| Name of medicine | Trulicity |
| INN | dulaglutide |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information | Trulicity: Pending EC decision |
| Name of medicine | Wakix |
| INN | pitolisant |
| Marketing-authorisation holder | Bioprojet Pharma |
| More information | Wakix: Pending EC decision |
| Name of medicine | Garsun |
| INN | artesunate |
| Marketing-authorisation applicant | B and O Pharm |
| More information | Garsun: Withdrawn application |
| Name of medicine | Imbruvica |
| INN | ibrutinib |
| Marketing-authorisation holder | Janssen-Cilag International N.V.; |
| More information | Imbruvica: Withdrawn application |
Conclusion of referral
| Name of medicine | Janus kinase (JAK) inhibitors |
| INN | tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib |
| More information | Janus kinase inhibitors (JAKi) |
Start of referral
| Name of medicine | Adakveo |
| INN | crizanlizumab |
| More information | Adakveo |