Enzalutamide (formerly MDV3100 ) New Drug Application

Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration-Resistant Prostate Cancer in Patients Previously Treated With Chemotherapy

SAN FRANCISCO, CA and TOKYO -- (Marketwire) -- 05/21/12 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) announced that Medivation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for enzalutamide (formerly MDV3100). The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.

Pursuant to the Prescription Drug User Fee Act (PDUFA), the FDA is expected to determine within 60 days whether to accept the filing for review. Medivation has requested Priority Review, a designation given to drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists. If a Priority Review is granted, the FDA goal for completing a review is six months.

about Enzalutamide (formerly MDV3100)
Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.

In the Phase 3 AFFIRM trial, enzalutamide was well tolerated. Common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in < 1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group.

about Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partner Astellas, Medivation currently has the investigational drug enzalutamide in Phase 3 development to treat advanced prostate cancer and in Phase 1 development to treat breast cancer. For more information, please visit us at www.medivation.com.

Thanks Robert I am putting this drug on my wish list, likely has low side effects like casodex but works superiorly to that. They have the early access program available right now, but you have to fail chemo prior I think it was. So hopefully gets approved soon, next is what is the cost, is it ridiculous or fair or in between????? Hope insurance covers it too.

The drug companies responsible for Abi, enzalutimide, and perhaps ARN-509, and the others in the similar pipeline would all LOVE to be used in the pre-chemo setting. The market is so much larger, the treatment time is much longer and the market penetration and profit would be so much greater than in the post-chemo only area. Aragon is taking its drug in Phase II with pre-chemo only assuming that they can beat the existing drugs in that area and save money on duplicating trials. The lawsuit with Medivation, notwithstanding.
Lawyers and money.
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In addition, this article about expanded access program:

Expanded Access Program for enzalutamide agreed with US FDA

| 30 May 2012

The US Food and Drug Administration agreed that Medivation (Nasdaq: MDVN) and Japanese drug major Astellas Pharma (TYO: 4503) may proceed with an Expanded Access Program (EAP) for their investigational prostate cancer therapy enzalutamide (formerly MDV3100) under a treatment protocol in the US while marketing approval is being sought from the FDA.

The EAP is now enrolling eligible men with metastatic castration-resistant prostate cancer previously treated with docetaxel chemotherapy. Medivation and Astellas intend for investigators at around 75 centers in the USA to participate in the EAP study to provide expanded access to enzalutamide until the drug becomes commercially available, should it receive approval. This study is sponsored by Medivation and Astellas Pharma Global Development.


"We are truly grateful that Astellas and Medivation worked closely with our volunteer committee from around the USA, to turn the vision of an Early Access Program into a reality. Our mission at the Early Access Program for Prostate Cancer patients (EAPPCa) is to assist in bringing potential new medications to the most advanced cancer patients after a successful Phase III trial and before a final FDA decision," Mark Moyad, of the University of Michigan Medical Center, Department of Urology, and Tom Kirk, president and chief executive of Us TOO International, said in a joint statement.