Bristol Myers Squibb (BMS) and the Janssen Pharmaceutical Companies of Johnson & Johnson have announced that all three prospective antithrombotic indications for milvexian have been granted fast track designation by the US Food and Drug Administration (FDA).
The designations for the investigational oral factor XIa inhibitor cover all three indication-seeking studies within the phase 3 Librexia development programme: ischaemic stroke, acute coronary syndrome and atrial fibrillation.
According to the companies, the programme aims to evaluate whether milvexian can enhance the benefit-risk profile associated with treating patients with these three conditions by delivering reduced thrombotic events with no increased risk of bleeding.
Librexia programme chair, Robert Harrington, said: “Despite major advances in cardiovascular and stroke treatment over the past two decades, millions of patients currently remain untreated or under-treated due to the risk of bleeding, but for whom thrombotic events could be prevented.
“If successful, milvexian could open the door to treat an entirely new set of patients who are currently overlooked due to bleeding risk.”
Milvexian will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate the review of drugs to treat serious conditions and fill an unmet medical need.
“For milvexian to receive fast track designation from the FDA for all three indications demonstrates the enormous unmet need that still exists for the treatment of thrombotic events, like heart attack and stroke,” said James List, global therapeutic area head at Janssen Research & Development, LLC.
List added: “We are now focused on enrolling patients to these trials with urgency, bringing us one step closer to potentially improving outcomes in a wide range of patients with thrombotic diseases.”
The announcement comes just a few days after BMS presented positive results from a phase 2 study evaluating its investigational antifibrotic treatment in patients with idiopathic pulmonary fibrosis (IPF).
The results showed treatment with 60mg of BMS-986278 reduced the rate of decline in percent predicted forced vital capacity, which assesses pulmonary function, by 62% compared to placebo.