Glaxo's Phase III PETIT2 Study Meets Main Objective

By Razak Musah Baba

LONDON--GlaxoSmithKline PLC (GSK.LN) said Friday the results from the Phase III PETIT2 study evaluating its drug eltrombopag in pediatric patients with low platelet count showed the main objective was met.

Glaxo said, eltrombopag--marketed as Promacta in the U.S. and as Revolade in Europe and other countries across the world--met its objective, achieving a statistically significant improvement in platelet counts with almost 40% of patients treated with eltrombopag attaining a consistent platelet response for 6 of 8 weeks compared with the placebo.

Dr. Rafael Amado, head of oncology research and development at Glaxo, said: "the PETIT2 study results presented today show an increase in platelet response rate with eltrombopag treatment--an important result given that these children had failed other standard therapies."

"We look forward to continuing to assess the potential of eltrombopag in these patients and to moving forward with planned regulatory submissions for a pediatric indication in cITP [chronic immune (idiopathic) thrombocytopenic purpura] later this year," Dr. Amado added.

Eltrombopag isn't approved or licensed anywhere in the world for use in chronic immune (idiopathic) thrombocytopenic purpura in the pediatric area.

Write to Razak Musah Baba at [e-mail]; Twitter: @Raztweet

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