The approval demonstrates the potential of Fasenra to help patients suffering from eosinophilic disease beyond severe asthma, Ruud Dobber, executive vice president of AstraZenecas biopharma business unit, said in a statement
In the agencys own words, it does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public.3 This means that its up to supplement manufacturers to take the necessary steps to ensure consumer safety
In turn, this has implications for evidence requirements for securing AOM reimbursement, e.g., the likely need for demonstrating functional and possibly outcomes benefits in obese patients
Onboarding runs about $1,200 to $1,500 all-in, covering labs, the scan, provider prep, and the hour-long consultation