Astellas Submits MAA To EMEA For Telavancin

Astellas Pharma Europe has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for telavancin.

Telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, is meant for the treatment of nosocomial pneumonia (NP), including ventilator-associated pneumonia, and complicated skin and soft tissue infections (cSSTI) in adults.

Masao Yoshida, president and CEO of Astellas Pharma Europe, said: “We are extremely pleased that this critical step has now been completed. We look forward to working with the regulatory authorities and our partner, Theravance, to efficiently progress telavancin through the remaining steps to approval.”

Rick Winningham, CEO of Theravance, said: “The MAA submission represents an important step toward our goal of making telavancin globally available to physicians and patients. We will work closely with our partner Astellas in seeking the approval of telavancin in the EU.”