Tag Archives: orphan cancer drug market overview

Novel PAH treatment receives FDA orphan drug designation

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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FDA approves Soricimed’s SOR-C13 as orphan drug for pancreatic cancer

Peptide SOR-C13 of Soricimed Biopharma Inc., known for discovering and developing peptide based cancer therapeautics, has been granted as orphan drug designation for the treatment of pancreatic and ovarian cancer by Food and Drug Association (FDA), U.S.

Pancreatic cancer, being the eleventh most common cancer and third leading cause of cancer related deaths in United States, causes approximately 53,070 deaths per year in U.S and 330,000 per year deaths per year worldwide.

According FDA, orphan drug designation status is given to those drugs or medication which helps in the treatment of rare and severe diseases, keeping in mind the potential benefit of product treating the disease. FDA defines rare diseases as those which affects. Peptide SOR-C13, if approved for commercialization by the FDA, SOR-C13 may qualify for seven years of marketing exclusivity in the United States for this indication. In certain cases, it can be made available for patients before marketing approval of compassionate use.


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Resunab by Corbus Pharma receives Orphan drug status by EC

Corbus Pharmaceutical Holdings Inc. announces that its leading asset has been granted orphan drug designation by European Commission for the treatment of patients with Cystic Fibrosis. Resunab is the synthetic oral endocannabinoid-mimetic drug.

The pharmaceutical firm previously announced that the drug has been granted orphan drug status and fast track status for the treatment of systemic sclerosis by the US food and Drug Association (FDA). Currently, the drug is undergoing three clinical studies in phase 2 trials for Cystic Fibrosis, Systemic Sclerosis and dermatomyositis. Furthermore, the drug is expected to undergo clinical study for treatment of systemic lupus erythematosus in the first quarter of 2017.

The European Commission grants orphan medicinal product status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. The orphan medicinal product status designation provides the company and its drug with certain benefits and incentives in the EU, including a period of market exclusivity.

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