The newest indication for Reclast—postmenopausal osteoporosis—ups its market potential considerably, analysts said.

The FDA green light of zoledronic acid injection for treating the brittle bone disease marks the first time a drug has been approved as a once-yearly osteoporosis therapy, Novartis said. With European approval for the indication looking imminent, Bear Sterns forecasted the drug’s global sales at $100 million this year, reaching $550 million by 2012. About $300 million of that will come from the US.

While Reclast is already available in the US and EU for Paget’s disease, Novartis has not been doing any DTC advertising due to the relatively small patient population involved: roughly one million Americans suffer from the bone disorder. But osteoporosis affects eight million people in the US, and Novartis estimates the US osteoporosis market at $4.5 billion, half of which is comprised of oral bisphosphonates.

The drug maker is likely to use DTC to go after some of that market. McCann HumanCare has been secured to handle DTC for the brand. (Sister agency Regan Campbell Ward-McCann handles the physician side, and McCann Healthcare has the professional account in a number of ex-US markets.) Other Interpublic Group shops are lined up to assist: relationship marketing duties reside with MRM Worldwide, which shares US experiential marketing work with Momentum Worldwide.

Novartis would not comment on its marketing plans, but if the Swiss firm adheres to the voluntary six-month blackout period, consumers would not see any new ads before year’s end. 

The FDA decision comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) recommended approval for the medicine in the European Union. The European Commission generally follows the CHMP’s recommendations and is expected to issue a final decision within three months. In the EU, the drug is sold under the name Aclasta.

Along with Aclasta, CHMP recommended approval of type 2 diabetes drug Galvus and Alzheimer’s patch Exelon—a bit of good news for Novartis, which has suffered some regulatory setbacks in the form of a US approvable letter on Galvus. Some also doubted Aclasta’s approvability, due to some level of atrial fibrillation seen in clinical trials, according to Bear Sterns. “These recommendations should be very positive for sentiment,” the research firm said.