FDA's approval: overwhelmingly positive results, late-stage study of Orladeyo.
"There are other FDA-approved HAE drugs on the market. However, Anthony Castaldo, CEO of the U.S. Hereditary Angioedema Association, noted that Orladeyo is "the first orally administered non-steroidal option for preventing HAE attacks." He added that the approval of the drug "represents an important and welcome step in making more treatment options available to physicians and patients."
Two(2) other key approvals for its HAE drug soon: 1). Japanese regulators should make an approval decision this month, and 2). European Medicines Agency could approve Orladeyo early in 2021.