FDA approves Shionogi’s Mulpleta
The Food and Drug Administration has given the green light for Shionogi’s Mulpleta (lusutrombopag). The product is indicated for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
“We are very pleased the FDA has approved Mulpleta as a new, safe and effective treatment,” said Takayuki Yoshioka, Shionogi’s president and CEO. “This new therapy offers physicians and patients another choice beyond platelet transfusions as adult patients with CLD often undergo procedures that could put them at increased risk for bleeding.
The product’s approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 109/L. Patients were randomized 1:1 to receive 3 mg of lusutrombopag or placebo once daily for up to seven days.
Assembly Biosciences gets FDA fast track for hepatitis B treatment
Assembly Biosciences has been granted Food and Drug Administration fast-track designation for ABI-H0731 for the treatment of patients with chronic hepatitis B infection.
ABI-H0731 is Assembly’s lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients, the company said.
“More than one million individuals in the United States suffer from chronic hepatitis B infection, which can progress to cirrhosis and liver cancer, eventually leading to death. Despite existing antiviral therapies, cures are rare, so the need for more effective and potentially curative treatments is tremendous,” Assembly Biosciences chief medical officer Uri Lopatin said. “We are encouraged that ABI-H0731 was granted Fast Track Designation. This will allow us to work closely with the FDA in our efforts to bring this new therapy to HBV patients as quickly as possible.”
Kroger’s Little Clinic gets Joint Commission accreditation
The Little Clinic, Kroger’s retail clinic subsidiary has received the Gold Seal of Approval from independent accreditor the Joint Commission, the company announced Wednesday. To receive the accreditation for the fourth time, the Little Clinic was required to demonstrate continuous compliance with the organization’s standards.
‘At Kroger Health, our vision is to help people live healthier lives Wellness Your Way, and the Little Clinic is a big part of that effort,” said Chance Cole, vice president of Kroger Health. “We’re focused on providing solutions that simplify the health care experience while also elevating the standard of care for people across the country. The reaccreditation by The Joint Commission further supports that work, and is a testament to the quality of care and operations provided by our clinics and our health care professionals.”
The Cincinnati-based Little Clinic had previously earned accreditation in 2009, 2012 and 2015, Kroger said. The Joint Commission said that its review process involved a team of general and retail health care-focused surveyors who evaluated compliance in such categories as coordination of care, infection prevention and control, medication management and patient education, among others.
“The Little Clinic takes great pride in receiving accreditation from The Joint Commission, the most trusted health care quality improvement and accreditation body in the nation,” said Marc Watkins, the Little Clinic’s chief medical officer. “We hold our team to the highest standards, and this recognition demonstrates that we are collectively continuing to keep that bar high. I’m excited about what we’ve built, but even more excited about where we’re headed. We’re committed to changing the way health care is delivered in this country and this another important milestone on that journey.”
Kroger said that the Little Clinic serves roughly 2 million patients per year at more than 200 Kroger banner stores. Its clinics are staffed by more than 500 nurse practitioners and physician assistants who can diagnose and treat common illnesses, minor skin conditions and injuries, as well as offer physicals, health screenings and vaccinations.