Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023

News 27/01/2023

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The application for marketing authorisation for Garsun* was withdrawn.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and rituximab in patients with previously untreated mantle cell lymphoma, a cancer of a type of white blood cell, was withdrawn.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.

January 2023 CHMP highlights

*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 medicineSotyktu
International non-proprietary name (INN)deucravacitinib
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
Therapeutic indicationTreatment of moderate to severe plaque psoriasis in adults
More informationSotyktu: Pending EC decision

Positive recommendations on new generic medicines

Name of medicineDapagliflozin Viatris
Marketing-authorisation applicantViatris Limited
Therapeutic indicationTreatment of type 2 diabetes mellitus, heart failure and chronic kidney disease
More informationDapagliflozin Viatris: Pending EC decision


Name of medicineSitagliptin / Metformin hydrochloride Sun
INNsitagliptin / metformin hydrochloride
Marketing-authorisation applicantSun Pharmaceutical Industries Europe B.V.
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSitagliptin / Metformin hydrochloride Sun: Pending EC decision


Name of medicineTolvaptan Accord
Marketing-authorisation holderAccord Healthcare S.L.U.
Therapeutic indicationTreatment of low blood sodium levels in adults secondary to the syndrome of inappropriate antidiuretic hormone secretion
More informationTolvaptan Accord: Pending EC decision


Negative recommendation on new medicine

Name of medicineSohonos
Marketing-authorisation holderIpsen Pharma
Therapeutic indicationTreatment of fibrodysplasia ossificans progressiva
More informationSohonos: Pending EC decision


Positive recommendations on extensions of indications

Name of medicineByfavo
Marketing-authorisation holderPAION Deutschland GmbH
More informationByfavo: Pending EC decision


Name of medicineDupixent
Marketing-authorisation holderSanofi Winthrop Industrie
More informationDupixent: Pending EC decision


Name of medicineNubeqa
Marketing-authorisation holderBayer AG
More informationNubeqa: Pending EC decision


Name of medicineReblozyl
Marketing-authorisation holderBristol Myers Squibb Pharma EEIG
More informationReblozyl: Pending EC decision


Name of medicineTrecondi
Marketing-authorisation holdermedac Gesellschaft für klinische Spezialpräparate mbH
More informationTrecondi: Pending EC decision


Name of medicineTrulicity
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationTrulicity: Pending EC decision


Name of medicineWakix
Marketing-authorisation holderBioprojet Pharma
More informationWakix: Pending EC decision


Withdrawal of initial marketing authorisation application

Name of medicineGarsun
Marketing-authorisation applicantB and O Pharm
More informationGarsun: Withdrawn application


Withdrawal of post-authorisation marketing authorisation application

Name of medicineImbruvica
Marketing-authorisation holderJanssen-Cilag International N.V.;
More informationImbruvica: Withdrawn application


Conclusion of referral

Name of medicineJanus kinase (JAK) inhibitors
INNtofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib
More informationJanus kinase inhibitors (JAKi)


Start of referral

Name of medicineAdakveo
More informationAdakveo


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