FDA accepts NDA for new formulation of abiraterone acetate


In  January and May this year we had noted that a company called Churchill Pharmaceuticals has been developing a different formulation of ultramicron-sized, oral abiraterone acetate (to be called Yonsa™).

According to a company media release issued earlier today, the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application for review, and has set a target date for completion of this review by March 19, 2018. If approved the drug would be used for the treatment of metastatic, castration-resistant prostate cancer.

Yonsa will need to be taken in combination with a drug known as methylprednisone — as opposed to the prednisone normally used in combination with the currently approved form of abiraterone acetate (Zytiga).

It seems reasonably likely that the FDA will approve Yonsa some time in 2018. However, there may still be legal issues to play out here related to patents associated with the development and manufacture of Zytiga.

2 Responses

  1. Since Yonsa is a 500 mg dose, compared to Zytiga’s 1,000 mg dose, it will be interesting to see if Churchill Pharma sets the price of Yonsa at half the price of Zytiga. The skeptic in me is doubtful this will be the case.

  2. Len:

    Since abiraterone acetate will come off patent in the not too distant future, there may be some dramatic changes to the price of the original formulation. This may also have impact on what it is feasible to charge for Yonsa. We’re just gonna have to wait and see what happens with that.

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