Update for August 4, 2021

Regulatory Update
 
The FDA approved anifrolumab (Saphnelo, AstraZeneca), on 8/2/2021, for the treatment of moderate to severe systemic lupus erythematosus (SLE). Anifrolumab will compete with belimumab (Benlysta).
 
The FDA accepted the BLA for Roche’s faricimab for the treatment of neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME) suggesting a PDUFA date of 1/28/2022.
 
The EMA gave PRIME status to Mustang Bio’s MB-107 for the treatment of X-linked severe combined immunodeficiency in newly diagnosed infants.
 
Announced Research Updates
 
A new draft report from ICER reviewing efgartigimod and eculizumab for the treatment of myasthenia gravis found moderate certainty of a comparable, small, or substantial net health benefit for efgartigimod compared to eculizumab due to uncertainties about dosing and long-term benefits. When estimating pricing ICER found the drugs to be cost effective at an estimated price of $21,800 for efgartigimod and $19,500 for eculizumab to achieve a $150,000 per quality of adjusted life year (QALY). This compares to the current list price of $653,100 with a discounted price of $470,000 for eculizumab
 
Published Research Updates
 
In a 14.7 month, 31 patient, open-label, Phase II trial, treatment with penpulimab plus anlotinib resulted in an objective response rate of 31% in Chinese patients with unresectable hepatocellular carcinoma.