BESREMi® (Ropeginterferon alfa-2b) deemed safe and efficacious by the US FDA
BESREMi® (Ropeginterferon alfa-2b) deemed safe and efficacious by the US FDA
Wien (pts026/15.03.2021/15:15) -
The US Food & Drug Administration (FDA) issued a complete response letter for the drug BESREMi® with the active pharmaceutical ingredient Ropeginterferonalfa-2b, in which the FDA confirms the efficacy and safety of the drug. This assessment was based on the clinical development program by the European rare disease company AOP Orphan.
On March 12, 2021, according to PharmaEssentia Corp., the FDA in the United States issued a so-called Complete Response Letter in respect to the submission of BESREMi® (Ropeginterferonalfa-2b) for the treatment of polycythaemia vera, a rare form of blood cancer. The Complete Response Letter confirms the safety and efficacy of BESREMi® in compliance with FDA regulations. The Complete Response Letter comes almost a year after PharmaEssentia s application to t
European ICU Drug Supports Patients in Canada
European ICU Drug Supports Patients in Canada
Vienna (ptp026/01.02.2021/14:55) -
Development and clinical data from the European Healthcare company AOP Orphan form the basis of the introduction of a new drug in Canada for rapid heart rate control in the hospital setting. Trimedic Therapeutics is about to become the Canadian market authorization holder and exclusive distributor.
Strokes, heart failure, heart attacks and sepsis are four of the six leading causes of hospital deaths according to the Canadian Institute for Health Information. AOP Orphan Pharmaceuticals AG (AOP Orphan) has been conducting several clinical studies to further confirm the important benefits of a super-selective, short-acting and rapidly reversible beta-blocker for patients in acute care. The medication is administered intravenously and fulfills an unmet medical need: It is administered in life-critical conditions, where it is desirable to safely and rapidly
AOP Orphan: PAH Treatment for Patients in Argentina
AOP Orphan: PAH Treatment for Patients in Argentina
Wien (pts030/26.01.2021/14:35) -
The Austrian pharmaceutical company AOP Orphan joined forces with the Argentinean company Tuteur to bring treatment to patients in Argentina suffering from Pulmonary Arterial Hypertension (PAH). The respective agreement was signed in December 2020.
AOP Orphan Pharmaceuticals AG (AOP Orphan) is a European pioneer in the field of special diseases offering treatment for PAH patients: A permanent subcutaneous application via a pump. The therapy increases life expectation and quality of life, i.e. allowing patients to walk (again) longer distances without being out of breath and following a rather normal every-day life. To achieve this improved quality of life, it is not only the drug that is needed, but a lot of knowledge and experience with the general therapy approach. Business partners like Tuteur use this know-how as part of the package. This