(Reuters) - Drug developer BioMarin Pharmaceutical Inc said the U.S. Food and Drug Administration told the company that it would not be able to decide on the marketing approval of its lead drug as scheduled, the second setback for the company.

Shares of the company were little changed in premarket trading. They closed at $100.64 on Thursday on the Nasdaq.

The FDA was set to decide on the approval by Dec. 27, and the agency anticipates giving its decision in early January, the company said on Friday.

BioMarin said the federal agency had not yet completed the review of the drug, which is designed to treat rare disorder Duchenne muscular dystrophy (DMD).

BioMarin's DMD drug, to be named Kyndrisa on getting the FDA nod, was expected to be the first treatment for the muscle wastage disorder that affects one in 3,600 newborn boys and causes rapid muscle degeneration.

However, data submitted by the company from studies did not persuade a panel of outside advisers to the FDA that the drug worked in DMD patients.

BioMarin's closest competitor Sarepta Therapeutics Inc's experimental DMD drug, eteplirsen, which works in similar way, is also expected to face a tough review by FDA staff and a panel of experts.

(Reporting by Vidya L Nathan in Bengaluru; Editing by Sriraj Kalluvila AND Shounak Dasgupta)