FDA Rejects AstraZeneca's SubQ Saphnelo
The FDA sent a rejection letter to AZ this week regarding the self-administered Lupus drug, Saphnelo. The monoclonal antibody medication is currently approved for administration via IV infusion in a doctor's office, hospital, or infusion center. Saphnelo SC can be administered by patients at home with the same clinical results. Neither the FDA nor AZ specified the reason for the rejection, but AZ said it is “committed to working with the FDA to progress the application as quickly as possible.”
PreCheck Pilot Program Officially Launches
This week, the USDA started officially accepting applications to the
FDA's new PreCheck pilot program, which according to the FDA press release, is "designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application." That's a fancy way of saying the FDA wants to work with manufacturing facilities in the U.S. early and often in the design process, to encourage more development.
New ADHD Drug Reaches Priority Review
Otsuka Pharmaceutical's new treatment for ADHD in all ages,
centanafadine, made it to the FDA's priority review process last week. The drug is an NDSRI -- norepinephrine, dopamine, and serotonin reuptake inhibitor -- designed for once-daily extended release. Anyone who has treated patients with ADHD knows that a once-daily medication could be meaningful to those who often forget the second dose, or can't tolerate the multiple pill regimen sometimes needed to treat symptoms.
Pfizer's GLP-1 Trial Looking Positive
The
Phase 2b trial of Pfizer's GLP-1 receptor agonist is going well, according to the pharmaceutical company. Patients in this section of the trial kept losing weight after switching from weekly to monthly dosing. Good news for Pfizer, as they spent $10 billion acquiring obesity biotech company Metsera after a protracted bidding war with Novo Nordisk.