Genentech’s Hemlibra just got approved but is expected to bring in around $2 billion in peak sales.
This opinion piece presents the opinions of the author. It does not necessarily reflect the views of BioSpace.
There have been six new chemical entities approved since our last issue, bringing the year-to-date total to 40. (FDA) doesn’t count the CAR-T approvals in its official NCE list, presumably because these are customized for patients and thus aren’t a distinct chemical entity). This month’s crop includes a few drugs that are perhaps a little less than thrilling to many audiences (like a new ophthalmic solution for glaucoma and a new treatment for CMV).
But Genentech’s Hemlibra is anything but boring. This drug for hemophilia A is expected to bring in around $2 billion in peak sales. But at least one banker--Jeffries--thinks it is “significantly underplayed” and could reach $5 billion in sales. It is used to treat hemophilia A patients who have developed antibodies to Factor VIII, which is quite common. AstraZeneca’s severe asthma drug Fasenra may not quite reach that level, but former CEO Pascal Soriot has suggested it could reach $2 billion in sales (analysts are aiming a little lower). Calquence, a second-line drug for mantle cell lymphoma, could also potentially reach blockbuster status.
Mepsevii, for mucopolysaccharidosis type VII (Sly syndrome), probably won’t be a big seller, but it marks an important advance for the estimated 200 patients in the developed world who have this ultra-rare disease, and a critical first approval for newly public Ultragenyx. -KT
Here’s a roundup of these stories and other top FDA actions from the past month.
- FDA Approves Genentech’s Hemlibra, the First Drug in 20 Years for Hemophilia A With Inhibitors
- FDA Approves Ultragenyx’s Treatment for Rare Genetic Enzyme Disorder
- AstraZeneca Release: FASENRA (benralizumab) Receives U.S. FDA Approval for Severe Eosinophilic Asthma
- AiCuris to Pocket $122M as Merck Wins FDA Approval for New CMV Infection Drug
- CALQUENCE (Acalabrutinib) Approved for Previously-Treated Mantle Cell Lymphoma, Available for Order at Biologics, Inc.
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