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Orphan Drugs: Recent Global Regulatory Events

May 4, 2013

There are recent global regulatory events for orphan drugs which are discussed and reviewed in this Blog Post.

Protalix BioTherapeutics And Gaucher Disease

Protalix BioTherapeutics announces April 29, 2013, that Uplyso (Elelyso outside of Latin America) is granted regulatory approval from the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) and the Public Health Institute of Chile, for the long-term Enzyme Replacement Therapy (ERT) for adults with Type 1 Gaucher Disease. Pfizer, Protalix BioTherapeutics’ commercialization partner, will market Uplyso in Mexico and Chile. The drug is approved by the US FDA in May 2012 and has also received regulatory approvals in Israel, Brazil, and other countries.

Celgene And Revlimid

An European Medicines Agency’s (EMA) panel recommends orphan drug Revlimid for a new indication – anemia in patients with blood disorders called Myelodysplastic Syndromes (MDS).  The EU is expected to make a final decision within three months. Revlimid is already approved in the US for this indication.

Celgene is also doing clinical trials for Revlimid for other indications to win new marketing approvals. New approvals for new indications for Revlimid is part of Celgene’s growth strategy. The other indications are :

•   Chronic Lymphocytic Leukemia
•   Non-Hodgkin Lymphoma
•   Myelodysplastic Syndromes.

According to Finance.Yahoo.com, “Celgene expects to report about $6 billion in revenue in 2013, with a $4.1 billion – $4.2 billion coming from Revlimid sales.”

Please Note: “Globe and Books” by AlphaZeta (Own work) [CC0] | via Wikimedia Commons

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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