FDA accelerates review for drug that treats blood-clotting disease
Medication for a potentially lethal hereditary disease will undergo an accelerated FDA approval process likely to bring it quickly to market, according to a recent announcement from manufacturer Shire Plc.
The condition, known as hereditary thrombotic thrombocytopenic purpura (hTTP), causes dangerous blockages in the body’s small blood vessels.
The FDA’s accelerated approval process was granted to Shire’s recombinant ADAMTS13, a substance linked to the disease, based on early tests. Although early testing yielded positive results, the fast-track designation does not assure the drug will ultimately reach the market.
Philip J. Vickers, chief of Shire’s research and development division, said that the FDA’s decision “reaffirms the significant unmet need that exists for this patient population and provides hope of reducing morbidity in patients with hTTP.”
The next step will be to test the medication under controlled, Phase 3 clinical conditions, typically the final step before a medicine can be prescribed by physicians.
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