Johnson & Johnson's
) Janssen Research & Development, LLC recently submitted a
supplemental New Drug Application (sNDA) seeking US Food and Drug
Administration (FDA) approval for Zytiga (abiraterone acetate). A
marketing application was submitted in the EU as well. Johnson
& Johnson is looking to get Zytiga's label expanded for use in
chemotherapy-naïve patients with metastatic castration-resistant
prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic
after failure of androgen deprivation therapy.
The regulatory applications for label expansion were filed soon
after Johnson & Johnson presented promising results from
pre-specified interim analyses of an international phase III,
randomized, double-blind, placebo-controlled COU-AA-302 study. The
study was conducted to evaluate the efficacy and safety of Zytiga
plus prednisone versus placebo plus prednisone. The co-primary
endpoints of the study were radiographic progression-free survival
(rPFS) and overall survival (OS).
Results indicated a statistically significant improvement in
rPFS and all secondary endpoints in the Zytiga arm. A trend
for increased median overall survival was also observed in the
Zytiga, an oral, once-daily medication, is currently approved
for use in combination with prednisone for the treatment of mCRPC
in treatment-experienced patients whose chemotherapy contained
docetaxel. While US approval came in April 2011, EU approval was
granted in September 2011.
Zytiga is one of the most important and successful new product
launches at Johnson & Johnson. Approval for the
chemotherapy-naïve patient population would increase Zytiga's sales
potential significantly. If approved for the chemotherapy-naive
indication, Zytiga will be used in patients at an earlier stage of
Another company looking to enter the prostate cancer market is
). Medivation and partner, Astellas Pharma Inc., are seeking FDA
approval for enzalutamide for use in castration-resistant prostate
cancer patients who have received docetaxel therapy.
We currently have a Neutral recommendation on both Johnson &
Johnson and Medivation. While Johnson & Johnson carries a Zacks
#2 Rank (short term 'Buy' rating), Medivation carries a Zacks #3
Rank (short term 'Hold' rating).
JOHNSON & JOHNS (JNJ): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
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