Astellas and Theravance Submit Telavancin MAA for the Treatment of Nosocomial Pneumonia and Complicated Skin and Soft Tissue Infections in Europe
Thu, 10/29/2009 - 4:52am
Astellas and Theravance, Inc. announced today that Astellas Pharma Europe B.V. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia (NP), including ventilator-associated pneumonia, and complicated skin and soft tissue infections (cSSTI) in adults. "We are extremely pleased that this critical step has now been completed," said Mr. Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd. "We look forward to working with the regulatory authorities and our partner, Theravance, to efficiently progress telavancin through the remaining steps to approval." "The MAA submission represents an important step toward our goal of making telavancin globally available to physicians and patients," said Rick E Winningham, Chief Executive Officer at Theravance. "We will work closely with our partner Astellas in seeking the approval of telavancin in the European Union."