February 6, 2015 in Blog, News from Our Companies

Celtaxsys gets special FDA designation for cystic fibrosis drug

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Screen Shot 2015-02-06 at 3.40.05 PMCeltaxsys, a clinical-stage biotech firm and Graduate Company of the Advanced Technology Development Center at Georgia Tech, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration on its cystic fibrosis treatment.

The ODD designation for its once daily, oral leukotriene A4 hydrolase inhibitor (CTX-4430), follows a similar classification Celtaxsys received from the European Medicines Agency for the drug’s use in the European Union.

ODD classification is designed to entice pharmaceutical firms to develop drugs for diseases that considered rare or afflict a smaller number of people, relative to other illnesses. The drugs must undergo rigorous clinical trials and meet federal standards, but are eligible for tax incentives.

Cystic fibrosis, which affects about 70,000 globally, stems from a gene deficiency that causes the body to produce thick mucous in the the lungs, which leads to life-threatening infections, and the pancreas, interfering in the body’s ability to break down and absorb food. Read the full story at this link.




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