Posted from: Monday, September 17, 2018 - 11:57 AM - Present

Mulpleta Approved to Treat Thrombocytopenia

July 31, 2018 – The U.S. FDA has approved Mulpleta® (lusutrombopag), manufactured by Shionogi & Co. Ltd., to treat thrombocytopenia (low blood platelets) in adult patients who have chronic liver disease (CLD) and are scheduled to undergo a surgical procedure.

Mulpleta works by helping the body boost production of blood platelets. This may help to reduce the number of blood transfusions required by patients who have CLD, as these individuals often undergo numerous procedures with an increased risk of bleeding, and may require platelet transfusions prior to surgery.

In clinical trials, 65 to 78% of patients who received Mulpleta did not need platelet transfusions prior to undergoing clinical procedures. Just 13 to 29% of patients who received placebo achieved the same results. Recommended dosing is 3mg once daily, taken with food, for seven days. Patients should undergo their scheduled procedure two to eight days after treatment with Mulpleta.

The FDA’s approval of Mulpleta comes two months following its approval of Doptelet® (avatrombopag) from Dova Pharmecuticals. Doptelet carries the same indication as Mulpleta, with a similar safety and efficacy profile. However, Mulpleta may offer more flexibility in terms of the timing of surgical procedures, as treatment with Mulpleta can begin anywhere from 8 to 14 days prior to surgery, versus 10 to 13 days for Doptelet.

Mulpleta has been launched at an average wholesale price (AWP) of $10,200 for a seven-day supply. Doptelet, which was launched on May 31, 2018, is available at a wholesale acquisition cost of $9,000 for a five-day supply of its 40mg daily dose and $13,500 for its 60mg daily dose.

 

Last Updated Friday, October 19, 2018 - 05:45 PM.