Affymax And Takeda Announce A Nationwide Voluntary Recall Of All Lots Of OMONTYS® (peginesatide) Injection
Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited
(Takeda) today have decided to voluntarily recall all lots of OMONTYS
(peginesatide) Injection to the user level as a result of new
Please click here for Full Prescribing Information, including Boxed WARNINGS, also available at www.omontys.com.
OMONTYS Indication and Limitations of Use OMONTYS® (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is not indicated and is not recommended for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life. About Affymax, Inc. Affymax, Inc. is a biopharmaceutical company based in Palo Alto, California. Affymax's mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses. For additional information on Affymax, please visit www.affymax.com. Affymax Forward-Looking Statement This release contains forward-looking statements, including statements regarding the potential attributes and safety profile of OMONTYS, the continuation and success of Affymax's collaboration with Takeda and the commercialization of OMONTYS. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the recall and adverse events, ability to re-introduce OMONTYS to the market and future acceptance by dialysis organizations, patients and the medical community, and other factors affecting the commercial potential of OMONTYS, the continued safety and efficacy of OMONTYS, the industry and competitive environment, regulatory requirements or actions by the FDA or other regulatory authorities, including withdrawal, further changes to the label, post-marketing studies, trials and Risk Evaluation and Mitigation Strategy, the potential for disruptions to supply, potential litigation, financing requirements and our ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.