ARTICLE | Regulation
Lupus nephritis patients gain oral option as FDA approves Aurinia’s Lupkynis
Inclusion of dosing program in label could extend patent coverage
January 24, 2021 3:49 AM UTC
FDA’s approval Friday of Lupkynis voclosporin will allow Aurinia to introduce an oral therapy into a new marketplace for drugs to treat lupus nephritis, for which there had been no approved treatments before last month’s label expansion for GSK’s IV treatment Benlysta.
Aurinia Pharmaceuticals Inc. (TSX:AUP; NASDAQ:AUPH) believes Lupkynis could deliver more than $1 billion in annual peak revenue. Although dosing will vary from patient to patient, Chief Commercial Officer Max Colao said on a conference call Monday that Aurinia expects to realize average annual net revenue of about $65,000 per patient, taking into account rebates, other discounts and patient adherence...
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