EU Approves Mysildecard for Treating Pulmonary Arterial Hypertension

The European Medicines Agency (EMA) has approved Mysildecard, a generic medication containing sildenafil, for the treatment of pulmonary arterial hypertension (PAH). This condition causes high blood pressure in the lungs, severely limiting patients' physical capabilities.

Mysildecard is indicated for adults and children over one year of age, specifically targeting those classified in WHO functional classes II and III of PAH, which affect exercise capacity significantly. The approved dosage for adults is 20 mg taken three times daily, with dosage adjustments based on individual health conditions and concurrent medications.

PAH is characterized by the narrowing of blood vessels in the lungs, leading to reduced oxygen intake and increased difficulty in physical exertion. Mysildecard acts as a phosphodiesterase-type-5 (PDE5) inhibitor, which helps to relax and widen these blood vessels, alleviating symptoms of the disease.

The EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed the bioequivalence of Mysildecard to established sildenafil products, particularly Revatio and Viagra. Though not directly compared to Revatio, the committee concluded that Mysildecard offers comparable benefits and risks.

On September 15, 2016, the European Commission granted marketing authorization for Mysildecard, allowing its use across the EU. The approval followed a thorough evaluation process that deemed its therapeutic effect on PAH to be equal to its reference counterparts.

As a prescription-only medication, Mysildecard must be prescribed and monitored by healthcare professionals experienced in treating PAH. Healthcare providers are advised to review safety information included in the product’s summary and package leaflet.

This approval is particularly significant for patients unable to access other treatments, expanding the arsenal of medications available for managing PAH. By offering a cost-effective alternative to brand-name medications, Mysildecard may improve treatment accessibility across the EU.

Patients and caregivers are encouraged to read the complete product information or consult healthcare professionals for guidance on Mysildecard usage. The information is available in all official EU languages to ensure widespread understanding and compliance.