GlaxoSmithKline has announced that the FDA has granted full
approval for PROMACTA® (eltrombopag), an oral tablet that can raise platelet
counts in patients with the rare blood disorder chronic immune (idiopathic)
thrombocytopenic purpura (ITP) who have had an insufficient response to
corticosteroids, immunoglobulins or splenectomy.
PROMACTA initially received FDA orphan drug designation in May
2008 and accelerated approval in November 2008 for chronic ITP. The FDA
Accelerated Approval program offers a pathway to gain provisional marketing
approval for therapies that address unmet patient needs. Full approval of
the therapy requires completion of post-marketing clinical trials and commitments
that verify clinical benefit.
“Full approval of PROMACTA was based on clinical
studies that provide physicians and patients with a broader understanding of
its treatment effect and safety profile,” said Steven Stein, MD, V.P. of
Medicines Development, GlaxoSmithKline. “PROMACTA is a testament to
how the FDA Accelerated Approval Program supports development of therapies that
meet unmet patient needs. Patients with limited treatment options gained access
to PROMACTA while GSK conducted clinical studies that yielded additional
efficacy and safety data.”
