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.
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The application for marketing authorisation for Garsun* was withdrawn.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and rituximab in patients with previously untreated mantle cell lymphoma, a cancer of a type of white blood cell, was withdrawn.
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.
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.
The committee recommended converting the conditional marketing authorisation of the COVID-19 treatment Paxlovid to a standard marketing authorisation.
*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.