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GSK's Promacta wins 'breakthrough' status in severe aplastic anemia

 
• By Donna Young

The US FDA has granted breakthrough therapy designation to GlaxoSmithKline's Promacta (eltrombopag) as a treatment for cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy.

The US FDA has granted breakthrough therapy designation to GlaxoSmithKline's Promacta (eltrombopag) as a treatment for cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy.

Promacta, a thrombopoietin receptor agonist, which is sold outside the US as Revolade, currently is approved by the FDA as...

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More from Cardiovascular

UPDATED: Bayer Surprises With Phase III Win For Asundexian In Stroke

 
• By Kevin Grogan

Successful stroke data on the oral Factor XIa inhibitor represents the first Phase III success for the class and is a major boost for Bayer’s cardiovascular franchise.

Arrowhead’s Redemplo Approval Sets Up Standoff With Ionis’s Tryngolza

 
• By Jessica Merrill

Redemplo is Arrowhead’s first commercial product, and the drug will enter a competitive market. Arrowhead and Ionis have taken different pricing paths, however.

Merck’s Winrevair Poised For A CADENCE Of Growth

 
• By Jessica Merrill

A Phase II trial testing Winrevair in patients with a type of hypertension caused by heart failure met the primary endpoint and could represent a big growth opportunity.

BMS Sees Another Setback As Milvexian Fails Phase III Test

 
• By Mandy Jackson

Two Phase III trials of the Factor XIa inhibitor milvexian are ongoing in atrial fibrillation and secondary stroke prevention, but BMS and partner J&J stopped a third in acute coronary syndrome.

More from Therapy Areas

Lundbeck Concedes Avadel Bidding War, But Remains On The Hunt

 
• By Manas Mishra

Lundbeck does not plan to raise its offer for sleep specialist Avadel, clearing the way for Alkermes to win the two-way bidding war.

AstraZeneca Scores FDA Win For Imfinzi In Perioperative Stomach Cancer

 
• By Alaric DeArment

The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.

Satellos Tackles Duchenne ‘As Stem Cell People Solving a Stem Cell Problem’

 
• By Manas Mishra

Satellos is moving to start a double-blinded Phase II trial of its experimental Duchenne muscular dystrophy candidate that looks to mimic the effects of dystrophin on muscle stem cells.