Keywords: Astellas, citizen petition, immunosuppressants, organ transplants

Astellas Announces the Outcome of its Citizen Petition in the USA

Article | 11 August 2009

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Japan’s Astellas Pharma says that its North American affiliate has received notice that the US. Food and Drug Administration has substantially denied the company’s Citizen Petition, which had been submitted in September 2007, to ensure the safe and effective use of oral immunosuppressants used in organ transplant patients. In response, Astellas intends to file a complaint in US District Court in Washington DC challenging the FDA’s decision.

The company's shares lost 4.9% to 3,690 yen on August 11, compared with a 0.6% rise in the benchmark Nikkei 225 Stock Average.

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The purpose of this petition is to ensure the safe and effective use of orally-administered immunosuppressant used in transplant patients and characterized by a narrow therapeutic index (NTI).In this petition, Astellas requested that bioequivalence clinical trials in transplant patients be required for approval of substitute critical dose immunosuppressants. Additionally, Astellas will request labeling changes that require prescribing physicians to be notified if substitution of another oral immunosuppressant is contemplated by the pharmacist.
 
Astellas believes that the additional measures are necessary to ensure the safe and effective treatment in transplant recipients. The US unit plans to request the court to issue a preliminary injunction enjoining the FDA’s approval of abbreviated New Drug Application(s) for tacrolimus to ensure the safe and effective treatment in transplant recipients considering the fact that the validity of FDA’s decision is being disputed in the court.

At the same time that Astellas’ petition was rejected, Swiss drug major Novartis said its subsidiary Sandoz became the first and only company to receive FDA approval for generic tacrolimus.

SMBC Friend Research Center analyst Satoru Takaoki said investors sold the company's shares on concerns that the FDA approval of Sandoz' product will lead to more generic makers launching their own versions, reports Dow Jones. However, the newswire said, Nikko Citigroup analyst Hidemaru Yamaguchi took a more measured stance, saying that sales of Prograf (the US trade name) may not diminish as quickly as other brand-name drugs when the generic version is released.