Just two weeks after the FDA again rejected Lexicon Pharmaceuticals’ attempt to rescind a CRL in type 1 diabetes, the Texas biotech said the agency had accepted the heart failure drug’s resubmission.
A decision date is scheduled for May 2023. The regulator will consider two phase III trials, one in which worsening heart failure sent type 2 diabetes patients to hospital (SOLOIST-WHF) and another that includes patients with type 2 diabetes, chronic kidney disease and cardiovascular disease risk (SCORED). In total, sotagliflozin has been tested in 14 phase III trials in approximately 20,000 people.
The oral drug SGLT2 has come under fire in recent years, with the FDA making clear its rejection of the drug for the treatment of type 1 diabetes in March 2019, which at the time included partner Sanofi. The Big Pharma exited the scene a few months later, taking a $260 million hit.
Despite its failures in the United States, Lexicon won European Union approval for the drug in adults with type 1 diabetes in April 2019 and is sold as Zynquista.
The accepted filing triggers Lexicon’s ability to raise an additional $25 million through its loan facility with Oxford Finance. The biotech got the first tranche of $25 million in March and may receive another $50 million next year if the drug is approved for heart failure. A final $50 million can be used thereafter.
Bristol Myers buys future royalty obligations on mavacamten
Three months after picking up a big win over mavacamten, Bristol Myers Squibb has now bought out future royalty bonds on the drug for $295 million, Big Pharma has revealed in a filing with the SEC.
At the heart of MyoKardia’s $13 billion acquisition in 2020, mavacamten won an FDA nod in April for treating a condition in which blood is blocked from flowing from the heart.
MyoKardia and Cytokinetics co-discovered the drug, with the latter currently in late-stage trials for its own myosin inhibitor, aficamten. Royalty Pharma paid $50 million upfront in January and is prepared to pay an additional $100 million in biobucks for the royalty on the drug.
Despite Phase III failure, InflaRx brings Covid-19 drug to FDA
German biotech InflaRx said it would submit an application to the FDA for emergency use authorization for its Covid-19 monoclonal antibody.
The mAb, named vilobelimab, failed a late-stage study months ago in critically ill patients who were on mechanical ventilation for Covid-19. Despite the failed lawsuit, the company met with the FDA, and InflaRx said the Type B meeting led to “encouraging interactions” with the agency.
“With emerging variants and cases of COVID-19 and hospitalizations on the rise again, there remains an urgent need for new treatment options, especially for the sickest patients who experience an inflammatory response, leading to failure. organic. Our constructive interactions with the FDA and the helpful guidance they provided encouraged us to move forward with EUA’s application for vilobelimab in critically ill COVID-19 patients,” said CEO Niels Riedemann in a statement.