AstraZeneca announced that the European Commission has granted Marketing Authorisation to Zinforo ceftaroline fosamil an antibiotic, for the treatment of adult patients with complicated skin and soft tissue Infections or Community Acquired Pneumonia. The form of pneumonia is often contracted in hospitals and health care facilities.
The authorization was based on results from a Phase III trial.
Zinforo was also effective in treating vulnerable patient groups, including the elderly or those with conditions such as asthma.
The most common adverse reactions were diarrhoea, headache, nausea, and pruritus and were generally mild or moderate in severity.
“We are delighted that Zinforo has received regulatory approval across Europe and believe it will make a valuable contribution to addressing the significant unmet need for new antibiotics,” said Martin Mackay, president, R&D, AstraZeneca. “This is a key step in making Zinforo more widely available to patients across the globe and we will work with the appropriate health authorities, formulary and protocol reviews, and clinicians to bring this new antibiotic to patients as soon as possible.”
In 2009, Forest Laboratories Inc. granted AstraZeneca exclusive worldwide commercial rights and co-exclusive development rights for the drug, excluding US, Canada and Japan. Forest launched ceftaroline fosamil with similar indications under the trade name Teflaro in the US in March 2011.
AstraZeneca has manufacturing and administrative operations in northern Delaware.