In January this year we had mentioned that a company called Churchill Pharmaceuticals was developing a new “submicron” formulation of abiraterone acetate.
This morning we have been advised that Churchill has now submitted a New Drug Application (NDA) for approval of this formulation of abiraterone acetate to the US Food & Drug Administration (FDA). The full media release issued by Churchill Pharmaceuticals is available on line. The proposed brand name of the new product is Yonsa.
Note that
- This new formulation of abiraterone acetate is effectively a slightly different form of abiraterone acetate to that used in the original innovator compound (Zytiga).
- If and when approved by the FDA, Yonsa would need to be taken with a slightly different form of corticosteroid, known as methylprednisolone (as opposed to the prednisone that has to be taken with Zytiga).
The “New” Prostate Cancer InfoLink is not aware of any good reason to believe that either of these factors would have any significant impact on the therapeutic value of the abiraterone acetate.
Assuming that, in the opinion of the FDA, this new formulation of abiraterone acetate works just as effectively and safely as the original product, one might expect this new product to be available some time later this year (or at least early in 2018).
The degree to which this might impact the cost of treatment with abiraterone acetate is clearly unknown at this time. We also don’t know whether the new formulation of abiraterone acetate would be easier to take or would still have to be taken without food or could be taken in combination with food.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abirateone, acetate, Churchill, FDA, Yonsa |
THE "NEW" PROSTATE CANCER INFOLINK 
Abi is not usually taken in combination with food; when done so it is more potent as it is absorbed through the liver. Recent research suggests that when a reduced dosage is taken with food, it is equally effective.
Dear Sitemaster,
No need to publish this comment. I just wanted to point out two minor errors. The drug name is spelled methylprednisolone, not methylprednisone. Also, you state that “Zytiga will still have to be taken in combination with food” but right now, the instruction is to take Zytiga without food (no food 2 hours before and one hour after, according to the patient package insert). Thank you for providing the best summary of prostate cancer news available on planet Earth. :)
Yup. My error. Now fixed. Two people pointed this out to me. Too many balls in the air again! :O)