) has initiated a randomized, double-blind, placebo-controlled
phase III SUPPORT study (TRC112121) on Promacta (eltrombopag) plus
Vidaza (azacitidine) in intermediate-1, intermediate-2 or high risk
patients suffering from myelodysplastic syndromes (MDS).
In this study, the patients will randomly receive either
Promacta/Vidaza combination every 28 days for at least 6 cycles, or
placebo plus Vidaza. The primary endpoint of the study is to
compare the effect of Promacta/Vidaza combination with that of
placebo plus Vidaza in patients who who are platelet transfusion
free during the first four cycles. The company intends to enroll
350 patients in the study.
According to Glaxo, MDS gets evolved into acute myeloid leukaemia
(AML) in up to 45% of the patients. Approval of Promacta for the
additional indication would boost the drug's sales potential.
We note that Promacta has already been approved for the treatment
of thrombocytopenia in patients suffering from chronic immune
(idiopathic) thrombocytopenic purpura (cITP). The drug is also
approved for the treatment of thrombocytopenia in patients with
chronic hepatitis C virus (HCV) infection. Promacta is marketed in
Europe and other countries under the trade name Revolade.
Meanwhile, Glaxo is evaluating Promacta in pediatric patients for
the treatment of cITP. Earlier this month, the company announced
positive results from the phase III PETIT2 pediatric study.
Glaxo is also looking to expand Promacta's label. The drug is under
FDA review for the treatment of cytopenic patients with severe
aplastic anemia, who had responded insufficiently to
immunosuppressive therapy. With a Breakthrough Therapy designation
in the U.S., the review process for the candidate should speed
Glaxo has a licensing agreement with
) for Promacta.
Glaxo carries a Zacks Rank #3 (Hold). Some better-ranked stocks in
the health care sector include
ANI Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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