Noticias

Noticias

  • Título: FDA Approves Bayer’s Adempas to Treat Pulmonary Hypertension in Adults
  • Fecha: 09-10-2013

  • Berlin, October 9, 2013 – Bayer HealthCare announced today that the United States Food and Drug Administration (FDA) has approved Adempas® (riociguat) tablets for use in two forms of pulmonary hypertension, a group of life-threatening and progressive diseases: The treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

    Adempas is the only treatment approved in the US for use in two types of pulmonary hypertension. It is the only FDA-approved drug therapy for CTEPH that is inoperable or persistent/recurrent after surgical treatment. Last month, Adempas was approved in Canada in the CTEPH indication.

    “The FDA’s approval is a key milestone in our efforts to provide patients and physicians with a much-needed new treatment option for this rare, serious and potentially fatal disorder: It is the first drug to be approved for inoperable CTEPH or for persistent or recurrent disease after surgery, and it is also an important new class of treatment for patients with PAH,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

    “The clinical studies CHEST-1 and PATENT-1 met their primary endpoint by demonstrating a statistically significant improvement in exercise capacity as measured by the six-minute walk test (6MWT), a marker of disease severity and a predictor of survival in patients suffering from pulmonary hypertension,” said Principal Investigator Professor Ardeschir Ghofrani, University Hospital Giessen and Marburg, Germany. “Riociguat is the first drug to demonstrate efficacy in two distinct forms of pulmonary hypertension. The extent and consistency of improvements across both the primary and the multiple secondary endpoints as shown in the treatment with riociguat are impressive. CHEST-1 and PATENT-1 provide comprehensive information with regard to endpoints that form the basis for therapeutic decisions and are relevant in daily clinical practice for patients and their treating physicians, as e.g. six-minute walk test (6MWT), cardiopulmonary hemodynamics, WHO Functional Class and a disease-related biomarker.”

    PAH and CTEPH are two rare and life-threatening forms of pulmonary hypertension characterized by significantly increased pressure in the pulmonary arteries. The approval of Adempas is based on data from the two randomized, double-blind, placebo-controlled, global Phase III studies CHEST-1 and PATENT-1 as well as long-term data from CHEST-2 and PATENT-2 available at the time. These studies investigated the efficacy and safety of oral riociguat in the treatment of CTEPH and PAH respectively. Both Phase III studies, CHEST-1 and PATENT-1 met their primary endpoint, a change in exercise capacity, after 16 and 12 weeks respectively. Adempas also demonstrated consistent improvements across multiple, relevant secondary endpoints, and was generally well-tolerated, with a good safety profile.

    The most commonly reported adverse reactions, occurring in greater than or equal to 10 percent of patients under Adempas treatment (up to 2.5 mg TID), were headache, dizziness, dyspepsia, peripheral edema, nausea, diarrhea, and vomiting.

    Results of both studies were published in the New England Journal of Medicine (NEJM) in July 2013.

    The Phase III trial programs CHEST and PATENT are ongoing with the long-term extension studies, CHEST-2 and PATENT-2.

    In February 2013, Bayer HealthCare submitted riociguat for regulatory approval in the European Union and in May 2013 in Japan.

    Riociguat was discovered and developed by Bayer and is the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase (sGC).



  • Fuente: endovascular.es