Europe’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the approval of Wyeth Pharmaceuticals’ first-in-class antibiotic, Tygacil (tigecycline).
This marks the final step before formal approval, expected in the second quarter of this year, is given by European regulators to market the agent for the treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections in the 25 member states of the European Union, Iceland, Liechtenstein and Norway.
Wyeth has high hopes for Tygacil’s potential. A so-called broad-spectrum antibiotic, the agent is the first to be approved in a new class called glycylcyclines, and has shown activity against a number of bacteria, including the notorious drug-resistant bacteria methicillin-resistant Staphylococcus aureus, which is more commonly known as MRSA.
And, according to the firm, the introduction of Tygacil to the European market comes at a time when the need for new antibiotic options to combat serious infections is increasing. “Life-threatening infections are a growing concern globally,” said Dr Joseph Camardo, Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. “Bacterial infections are becoming more difficult to treat. Tygacil will provide physicians with an important option for patients.”
Tygacil was given a green light for use in the USA in June last year, and is now on formularies at more than 1,450 of the country’s largest hospitals, the company notes. Figures from the US Centres for Disease Control and Prevention show that people infected with drug-resistant organisms are more likely to have longer hospital stays and require treatment with multiple drugs, placing a substantial strain on the economy. In fact, it is estimated that antibiotic resistance costs the US between $4 billion and $5 billion each year, with antibiotic resistance now so widespread that many significant bacterial infections in the world are becoming resistant to commonly used antibiotics.