Global News

The FDA has granted fast track designation for the investigation of abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).

“Although there have been important advances in anticoa gulation treatment in the last 60 years, there remains a need for new agents that protect patients from having a stroke while offering a lower risk of bleeding than currently available anticoagulants. This is especially true for the elderly, patients with renal or hepatic impairment, and those with a prior history of bleeding,” said Peter Kowey, professor of Medicine and Clinical Pharmacology at Sidney Kimmel Medical College at Thomas Jefferson University, US.

“Factor XI inhibitors have the potential to uncouple the processes that lead to thrombosis from those that are involved in creating normal clots. By doing so, the hope is that this new class of anticoagulants will be at least as effective as current treatments – and have an enhanced safety profile. An alternative administration method and less frequent dosing will facilitate the care of patients who, for a variety of reasons, struggle with daily pill taking.”

The FDA has approved Fresenius Kabi’s biosimilar Stimufend (pegfilgrastim – fpgk), marking the first approved US biosimilar. This provides an accessible, high-quality treatment option for US cancer patients undergoing chemotherapy to reduce the incidence of infection as manifested by febrile neutropenia.

"This is a strategic milestone for Fresenius Kabi in one of the most important and fastgrowing markets for biopharmaceuticals," said Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius. "The company consequently expands its presence and position in the highly attractive US biosimilars marketplace in line with Vision 2026."

The company’s pegfilgrastim biosimilar is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common