EMA Committee Recommends 12 Orphan Drugs .

Mismo Status Otorgado tambien por la FDA de EEUU ( Link ) : The U.S. Food and Drug Administration (FDA) Has Granted Orphan Drug Designation to PharmaMar's Lurbinectedin.





**************************************

Feb. 8, 2019.

The European Medicine Agency’s Committee for Orphan Medical Products adopted 12 positive opinions for orphan treatments during its Jan. 22-24 meeting.

The Recommendations included PharmaMar’s Lurbinectedin for treating Small Cell Lung Cancer; Fondazione Telethon’s hemophilia B treatment; 3R Pharma Consulting’s losartan for treating epidermolysis bullosa; and Roche Registration’s risdiplam for treatment of spinal muscular atrophy.

The committee also recommended: FGK Representative Service’s infantile neuroaxonal dystrophy treatment; Enzyvant Therapeutics Ireland’s treatments for DiGeorge syndrome, CHARGE syndrome and severe combined immunodeficiency due to FOXN1 deficiency; Common Services Agency’s treatment of post-transplant lymphoproliferative disorder; and Clinical Network Services’ non-traumatic osteonecrosis treatment.

*******************