In its first meeting of 2023, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines for approval, providing positive opinions for two type 2 diabetes drugs.
Four new medicines recommended for approval
The CHMP recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults.
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 (CKD).
Sitagliptin/Metformin hydrochloride Sun (sitagliptin/metformin hydrochloride) for the treatment of type 2 diabetes mellitus.
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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
In the CHMP’s meeting, the committee recommended the refusal of a marketing authorisation for Sohonos* (palovarotene) for the treatment of fibrodysplasia ossificans progressive. This is a rare genetic disease that causes extra bone to form in places outside the skeleton, such as in joints, muscles, tendons and ligaments. Ultimately, this can lead to a progressive decrease in mobility and other severe impairments.
Recommendations on extensions of therapeutic indication for seven medicines
The group 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 at the CHMP’s meeting
The application for marketing authorisation for Garsun* was withdrawn in the CHMP’s meeting. 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in combination with bendamustine and rituximab in patients with previously untreated mantle cell lymphoma (MCL), was withdrawn.
Start of referral
The CHMP started a review of Adakveo. This medicine is indicated 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 EMA’s committee endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC). The organisation 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.
COVID-19 update
The CHMP 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 if the available information to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
CHMP meeting highlights – December 2022…
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