Exterior of EMA Headquarters.
Final meeting of the Committee on Medicinal Products for Human Use European Medicines Agency (EMA) has been flagged off four new drugs three of them General, On the other hand, the marketing recommendation of one drug has been rejected and the request for review of two others has been withdrawn.
There are three new generic drugs that have received a positive opinion from the EMA Dapagliflozin Vytris (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; why Tolvaptan Agreement (tolvaptan), for the treatment of adults with low blood sodium levels due to the syndrome of inappropriate antidiuretic hormone secretion.
is the fourth approved drug Sotyaktu (ducravacitinib) For the treatment of moderate to severe plaque psoriasis in adults, a skin disease that causes red, scaly patches.
For its part, the Committee recommended a refusal for marketing authorization. Sohonos (fire protection) For the treatment of fibrodysplasia ossificans progava, a rare genetic disease that causes the excess bone to form in places outside the skeleton, such as the joints, muscles, tendons, and ligaments.
7 Expansion of therapeutic indications of drugs
The committee also recommended seven indication extensions for medicines that are already authorized in the European Union (EU): Byfavo, Dupixent, Nubeqa, Reblozyl, Trecondi, Trulicity y Wakix.
On the other hand, the application for marketing authorization was withdrawn Garson, The drug was intended for the treatment of severe malaria caused by the Plasmodium falciparum parasite in patients in the European Union. The request to extend the therapeutic indication has also been withdrawn for rejected and Imbruvica in combination with bendamustine and rituximab in previously untreated patients with mantle cell lymphoma, a type of white blood cell cancer.
The committee has also started review he stayed A drug to prevent painful crises in patients with sickle cell disease, “following preliminary results from a study that raises questions about the drug’s efficacy.”
It has also endorsed the measures suggested by the Pharmacovigilance Risk Assessment Committee (PRAC) and issued a revised opinion to reduce the risk of serious side effects. Janus kinase (JAK) inhibitors Used to treat various chronic inflammatory disorders. These side effects include conditions Heart disease, blood clots, cancer and serious infections.
The information published in Redaccion Médica consists of confirmations, data and statements from official institutions and health professionals. However, if you have any queries regarding your health, please consult your respective health expert.
