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FDA approves new treatment for patients with hypoplasminogenemia

FDA approves new treatment for patients with hypoplasminogenemia
Today, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can impair normal tissue and organ function and may lead to blindness.
Until now, there were no FDA-approved treatment options for patients with plasminogen deficiency type 1. Today s approval helps address an unmet medical need for individuals affected by this rare genetic disease.
Peter Marks, M.D., Ph.D., Director, FDA s Center for Biologics Evaluation and Research
Individuals with this disease lack a protein called plasminogen, which is responsible for the ability of the body to break down fibrin clots. Plasminogen deficiency leads to an accumulation of fibrin, causing the development of growths (lesions) that can impair normal tissue and organ function and may lead to blindness when thes ....

Peter Marks , Emily Henderson , Prometic Biotherapeutics Inc , Drug Administration , Biologics Evaluation , Ryplazim Orphan Drug , Fast Track , Priority Review , Rare Pediatric Disease Priority Review , பீட்டர் மதிப்பெண்கள் , எமிலி ஹென்டர்சன் , உயிரியல் மதிப்பீடு , வேகமாக டிராக் , ப்ரையாரிடீ விமர்சனம் , ரேர் குழந்தை நோய் ப்ரையாரிடீ விமர்சனம் ,

FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder

/PRNewswire/ Today, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen. ....

Peter Marks , Veronika Pfaeffle , Prometic Biotherapeutics Inc , Drug Administration , Biologics Evaluation , Ryplazim Orphan Drug , Fast Track , Priority Review , Rare Pediatric Disease Priority Review , Us Food And Drug Administration , பீட்டர் மதிப்பெண்கள் , உயிரியல் மதிப்பீடு , வேகமாக டிராக் , ப்ரையாரிடீ விமர்சனம் , ரேர் குழந்தை நோய் ப்ரையாரிடீ விமர்சனம் ,