New drugs arriving and a confirmation on Pfizer’s anti-Covid pill
A negative opinion, four new drugs recommended for approval, seven to which the therapeutic indication has been extended and Pfizer's anti-Covid pill which is confirmed. All the latest EMA news
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), at its January meeting, recommended the approval of four new drugs and gave a negative opinion for another.
The latter concerned the marketing authorization of Sohonos (palovarotene) for the treatment of fibrodysplasia ossificans progressive, while the drugs that obtained a positive opinion are one for the treatment of plaque psoriasis, two for type 2 diabetes and one for the treatment of adults with low blood sodium levels caused by syndrome of inappropriate antidiuretic hormone secretion.
THE DRUG FOR PLAQUE PSORIASIS
The drug for the treatment of moderate to severe plaque psoriasis in adults is called Sotyktu (deucravacitinib) and the request was made by the US Bristol-Myers Squibb Pharma.
Plaque psoriasis is a skin disease that causes red, scaly patches. Sotyktu, according to the CHMP, is able to improve the condition of the skin and the most common side effects are upper respiratory tract infections, in particular nasopharyngitis.
THE TWO DRUGS FOR TYPE 2 DIABETES
The CHMP then recommended granting marketing authorization to two drugs for the treatment of type 2 diabetes , also known as adult-onset diabetes and which accounts for 90% of diabetes cases . It is a chronic noncommunicable disease characterized by high blood glucose levels and is due to an alteration in the amount or function of insulin.
Dapagliflozin Viatris (dapagliflozin) , the applicant for authorization of which is Viatris Limited, in addition to the treatment of type 2 diabetes is also recommended in case of heart failure and chronic kidney disease. It is a generic of Forxiga , authorized in the EU in 2012 and manufactured by AstraZeneca.
The other drug, also for the treatment of type 2 diabetes, is Sitagliptin/Metformin hydrochloride Sun (sitagliptin/metformin hydrochloride) , for which Sun Pharmaceutical Industries Europe applied. This is also a generic of Janumet , manufactured by Merck and licensed in the EU in 2008.
THE DRUG FOR THE LACK OF SODIUM IN THE BLOOD DUE TO INAPPROPRIATE SECRETION OF ANTIDIURETIC HORMONE
Accord Healthcare has received the green light for its Tolvaptan Accord (tolvaptan) to treat adults with low blood sodium levels caused by the syndrome of inappropriate antidiuretic hormone secretion, which is responsible for the reabsorption of water by the kidney.
Tolvaptan Accord is a generic of Samsca , authorized in the EU in August 2009 and manufactured by Millmount Healthcare Limited.
THE DRUG FOR FIBRODYSPLASIA OXIFICANS PROGRESSIVE REJECTED
The Committee also recommended the refusal of the marketing authorization of Sohonos (palovarotene) for the treatment of fibrodysplasia ossificans progressive, a rare genetic disorder that causes extra bone to build up in places outside the skeleton, such as joints, muscles, tendons and ligaments, resulting in progressively reduced mobility and other serious impairments.
THE 7 DRUGS TO WHICH THE THERAPEUTIC INDICATION HAS BEEN EXTENDED
The 7 medicines already authorized in the EU but which have now received an extension to the therapeutic indication are: Byfavo, Dupixent, Nubeqa, Reblozyl, Trecondi, Trulicity and Wakix.
WHO DRAWS BACK
Two applications, one for authorization and the other for extension of the therapeutic indication, have been withdrawn. The first concerns Garsun, a drug intended for the treatment of severe malaria caused by the Plasmodium falciparum parasite. The second was for the medicine Imbruvica in combination with bendamustine and rituximab in patients with mantle cell lymphoma, a cancer of a previously untreated type of white blood cell.
THE CONFIRMATION ON PFIZER'S ANTI COVID PILL
Finally, the CHMP recommended converting the conditional marketing authorization of Pfizer/BioNTech's Paxlovid anti-Covid pill into a standard marketing authorisation.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/nuovi-farmaci-in-arrivo-e-una-conferma-sulla-pillola-anti-covid-di-pfizer/ on Mon, 30 Jan 2023 09:43:24 +0000.