Camzyos wins in the Specialist Care category

Berlin. The hypertrophic obstructive cardiomyopathy (HOCM) is known during a chronic chronic myocardial hypertrophy (May in September), which causes an obstruction in the left ventricular flow path (LVOT). It is due to diastolic dysfunction with relaxation and compliance. Ursache est un fehlfunktion der Sarkomere mit excessivee images der Aktin-Myosin-Querbrücken.

With the cardials Myosin inhibitor Mavacamten (Camzyos^®) since July 2023, a drug therapy has started, which has been restored in the Krankheitsmechanism, and which compensates for the excessive treatment of Myosin-Aktin-Querbrücken-binding unterbindet. In these years, the Arznei of the Galenus-von-Pergamon-Preis in the Specialist Care category is awarded.

The medication is based on all the other candidates: “In studies, there were 80 reviews of the patients, who were treated in their own right, with medications”, erläuterte Professor Erland Erdmann, Vorsitzender of the Galenus-Jury, at the Preisverleihung in Berlin die Entscheidung der Jury. If there is such a large proportion of patients that the peculiar work is carried out, the medications are discussed, if it is all heavy, then it will be bad that there is a problem: ‘Ein derartiges Wirkprinzip gab es bisher noch nicht . It is a real innovation.”

Therapy can be used for symptomatic therapy (NYHA Class II – III) HOCM. In the Zulassungsonderzoek EXPLORER-HCM with 251 affected people, more than twice as many patients were found in the group treated with the Myosin Inhibitor and patients with the combined primary end point (improved oxygen faufnahme-capazität, reduction of the NYHA class). The LVOT gradient in the Ruhe and Belastung will change the cardinals of the biomarker NT-proBNP and hs-cTnI. Making a gain on the treatment of any of the results of a placebo means a significant spread of the KCCQ-23 CSS (Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score) that makes health-specific life quality.

In the VALOR-HCM study of 112 studies with HOCM, septal reduction therapy (SRT) is often used during therapy with therapy. The randomized placebo-controlled Phase III study was conducted with HOCM, while the maximum treatment medication contains the symptom files and a NYHA-Stage III or IV or a NYHA-Class II with Belastungssynkope or Präsynkope aufwiesen. After 16 treatment weeks there were 82 days of treatment with medical treatments. In the Placebo group the war dies on 23 Prozent der Fall.

Darüber can be used as a myosin inhibitor or relevant echo parameter for clinical symptoms, quality of life and cardiac biomarker. After 16 weeks, 63 percent of the patients have been treated in the same way as an NYHA class, 27 percent of them have been treated as two or more NYHA classes.

After completing the 16-fold double-blind phase, a further 16-fold active treatment phase follows, in all patients and patient mavacams. Before you start, it is a note for an SRT vorlag (primary study point), which is extended by the Mavacamten from Woche 16 to Woche 32.

Interim data from the laufende Extensionstudy MAVA-LTE bestätigen: The unter Mavacamten-Therapie therezielten Improvements of the LVOT-gradients, the NT-proBNP-Spiegels and the NYHA-Class have been stopped. These data were obtained from 231 patients and patients, where EXPLORER-HCM had been discontinued and the Mavacamten-Therapie continued (middle Beobachtungszeit 62 weeks).

As a Myosin Inhibitor, it would be treated in 2023 within the framework of the European Society for Cardiology with Management of Cardiomyopathies. Der Gemeinsame Bundesausschuss bestätigte in seinem Beschluss vom 1. February 2024 für Mavacamten einen beträchtlichen Zusatznutzen. This is based in particular on the aspects of health and safety because of the morbidity and symptoms of health-related quality of life. (kW/eb)