Novel PAH treatment receives FDA orphan drug designation

Release Date: 13-Dec-2016

Reviva pharmaceuticals announced that U.S food and Drug designation has granted orphan drug designation to its leading drug candidate, RP5603 for the treatment of pulmonary arterial hypertension (PAH). RP5603 is a combination of chemical modulation of dopamine and serotonin receptors. Pathogenesis of PAH and Serotonin 5-HT2A/2B receptors expressed in the lungs involves serotonin signaling and are recognized as novel targets for therapies for the treatment purpose.


Orphan Drug designation is granted to those medications or therapy that are rare, more specifically, affect less than 200,000 patients in the country. These rare diseases are incurable and severe in nature and may cause death. To fulfill the need of treat options for individuals, FDA grants orphan drug designation to drugs which are investigated to be helpful in the treatment of such rare diseases. Orphan drug status is a package of several financial benefits for the drugs and its manufacturers such as certain tax credits and exemption from paying prescription drug user fees normally required from companies submitting products for approval.


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