Pfizer said it expects a positive decision by the end of May on the inclusion of new pediatric data on labeling in Europe for its cholesterol drug Lipitor after European drug regulators recommended the move.
Recommendations by the European Medicines Agency's Committee for Medicinal products for Human Use (CHMP) are normally swiftly endorsed by the European Commission, and Pfizer said in a statement it expected a decision by the end of May.
The medicines agency's expert panel on Friday recommended a line extension to add chewable Lipitor tablets, a formulation developed for treatment of high cholesterol in adolescents and children aged 10 years or older.
"The CHMP also recommended that this indication be approved for the currently available presentations," it said. Once the decision has been confirmed, Pfizer will be able to market Lipitor, which is known generically as atorvastatin and sold under the name Sortis in some parts of Europe, with the new formulation and indication "in all EU member States where the medicine is authorized", the regulator said in a statement.
Lipitor, which lowers "bad" LDL cholesterol, is the world's biggest-selling drug, with annual sales of around $12 billion. Pfizer said the EU drugs agency's recommendation was based on data generated with a so-called pediatric investigation plan (PIP) that was filed in November 2009.
