This week in pharma:
Johnson & Johnson’s esketamine, or Spravato, won the agency approval on Tuesday, March 5, 2019. Spravato is a nasal spray whose structure stems from ketamine designed to treat major depressive disorder. Spravato will be the first blockbuster drug in decades for this disease state. The FDA mandated the medication to follow the “controlled distribution model” due to safety reasons and will only be distributed under healthcare provider supervision; the patient will have to be monitored for at least two hours after administration. Therapy begins as a twice per week treatment regimen for one month and can cost from $4,720-$6,785. Analysts predict $3 billion in peak sales.
Nasdaq takes a dip and Biopharma begins to worry as Scott Gottlieb resigns as FDA commissioner on Tuesday, March 5, 2019 for unclear reasons. Gottlieb had a passion for innovation and was responsible for expediting the drug approval process allowing for 59 new molecular entities to be approved in 2018— an all time high. An interim commissioner has not yet been named.
Abbvie, Gilead, and Merck submitted bids for Louisiana’s “Netflix” payment model for hepatitis C medications. This model allows the state to purchase an unlimited amount of hepatitis C medications for a fixed cost. The “Netflix” model aims to cure about 39,000 people in Louisiana's Medicaid and prison systems. Proposals are scheduled for later this month, and Louisiana plans to sign purchasing deals by June.
Recognizing the need for change, Eli Lilly introduces a generic Humalog, insulin lispro, that is half the price of Sanofi and Novo Nordisk’s biosimilars. One vial will cost $137.25 per vial or $265.20 for a pack of five pens; however, the price will only be offered to patients paying out-of-pocket. After Lilly received heavy, bipartisan support for their move, all eyes have turned to Sanofi and Novo Nordisk to see if they will follow suit or continue along a path that has been scrutinized by many.
As the FDA recovers from the valsartan recall, another extensive recall has been announced recalling nearly 200 lots of losartan-containing tablets. These lots were originally produced by Hetero Labs before being distributed by generic giants Camber, Aurobindo, and Torrent. The tablets contain the cancer-causing agent, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Although cancer risk is low, this has been the 3rd ARB medication recall within the lass year containing nitrosamine impurities.