Three candidates for FDA approval remain on BioWorld’s Drugs on Deck list for March, all of which have PDUFA dates scheduled for this month, even though most of the agency’s attention as of late is on the COVID-19 pandemic.
Ozanimod, a new multiple sclerosis treatment from Celgene Corp., which is now part of New York-based Bristol Myers Squibb Co., has its PDUFA date set for this Wednesday, March 25. The drug, an oral agonist of sphingosine 1-phosphatase (S1P) 1 and 5 receptors, was featured in BioWorld’s Drugs to Watch 2020 series published in February. If approved, sales could reach $1.6 billion by 2024, according to a Cortellis analysis. It may be easier to prescribe ozanimod if the FDA does not require a series of tests, such as electrocardiogram tests, needed for other drugs in its class, Gilenya (fingolimod, Novartis AG) and Mayzent (siponimod, Novartis AG).
Saint Laurent, Quebec-based Intelgenx Corp. is expecting an FDA decision on Thursday, March 26, for its Rizaport Versafilm product to treat acute migraines. It announced on March 23 that it would hold a conference call on Friday, March 27, to discuss the FDA’s anticipated decision and the company’s financial results, indicating all is on track for the candidate. Rizaport Versafilm is an oral thin film formulation of 5-HT1 receptor agonist rizatriptan benzoate.
Wixom, Mich.-based Rockwell Medical Inc. expects to get an answer by Saturday, March 28, for its intravenous iron product, Triferic, to treat end-stage renal disease and chronic kidney disease. The I.V. formulation would replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment. A week ago, the company entered a debt financing agreement with an affiliate of Innovatus Capital Partners LLC for up to $35 million in term loans, with $22.5 million funded at closing, and another $5 million drawn upon hitting milestones, such as the FDA approval for I.V. Triferic. A third tranche of $7.5 million is available to the company upon achieving milestones, including hitting certain Triferic sales thresholds. Triferic was developed under a special protocol assessment agreed upon with the FDA.
Finally, Deer Park, Ill.-based Eton Pharmaceuticals Inc.’s anti-epileptic ET-105 (lamotrigine) was slated for approval to treat Lennox-Gastaut syndrome on March 17, but the company announced in February that the FDA requested a human factors validation study that might delay things. A press release earlier this month said company officials expected to receive a complete response letter on the PDUFA date. Eton began drafting the study protocol and estimated a resubmission to the FDA would occur in the second or third quarter of 2020, allowing for final approval by the end of the year.