Astellas and Theravance submit marketing application

Astellas, in partnership with Theravance, has submitted a marketing authorisation application to the European Medicines Agency (EMEA) for the drug telavancin.

The bactericidal injectable lipogly copeptide antibiotic, designed to be taken once a day, is used for the treatment of nosocomial pneumonia, ventilator-associated pneumonia and complicated skin and soft tissue infections in adults.

It was developed by Theravance during a research programme conducted to find new antibiotics for serious infections brought about by Staphylococcus aureus and grampositive bacteria, such as MRSA.

Masao Yoshida, president and chief executive of Astellas, commented: “We look forward to working with the regulatory authorities and out parent, Theravance, to efficiently progress telavancin through the remaining steps to approval.”

Earlier this month, Astellas revealed that the Food and Drug Administration has granted an additional six months of paediatric exclusivity for its Flomax (tamsulosin hydrochloride) capsules.