CHMP issues positive opinions

The EMEA's CHMP issued several positive opinions, including one under "exceptional circumstances," on an application for Elaprase idursulfase from Shire (LSE:SHP; SHPGY) to treat mucopolysaccharidosis II (MPS-II, Hunter syndrome). In the case of Elaprase, the committee said that Hunter syndrome is sufficiently rare that the company cannot reasonably be expected to provide comprehensive safety and efficacy data. A BLA for the human iduronate-2-sulfatase was approved in July.

The committee also issued a positive opinion on Tandemact pioglitazone/glimepiride from Takeda (Tokyo:4502) to treat Type II diabetes in patients intolerant to or contraindicated for use of metformin. The fixed-dose combination of pioglitazone and glimepiride was approved in the U.S. in August under the name Duetact. ...