Lilly is setting up a voluntary Forteo patient registry to collect data on potential bone cancer risk as part of FDA's approval of a new indication for the osteoporosis treatment. The company is also instituting a Risk Evaluation and Mitigation Strategy to control for the risk.

On July 22, FDA expanded use of the injectable drug to include treatment of glucocorticoid-induced osteoporosis (GIO) in adult patients at high risk for fracture. The labeling for Forteo (teriparatide) has included a boxed warning about the potential risk of osteosarcoma since the drug was approved in 2002.

But because patients with GIO may be younger than those currently taking Forteo, Lilly updated the labeling to emphasize the drug should not be used in pediatric patients and young adults and established a patient registry to evaluate the long-term safety of the drug. Lilly said osteosarcoma is a serious but rare cancer which occurs at a rate of about four cases per million people per year and has rarely been reported in people who took Forteo.

REMS Includes Communication Plan, Med Guide

The expanded indication, however, means more people will be taking the drug. Lilly therefore plans to implement a REMS to warn health care providers and patients about the potential risk and the voluntary patient registry. It will also emphasize to health care providers that Forteo can be used no longer than two years over a patient's lifetime.

¹ Forteo's REMS includes a medication guide to be dispensed with every prescription and a letter to be mailed to health care providers likely to prescribe Forteo. A letter will also be mailed to new prescribers of the drug once per year for two years after the GIO launch.

In addition, Lilly representatives meeting with health care providers during the first six months of the launch of the GIOP indication will give them highlighted information for prescribers. That information describes the potential risk of osteoscarcoma and the patient registry.

Lilly noted in a press release that GIO is associated with chronic use of glucocorticoid medications, which are often prescribed for inflammatory conditions such as rheumatoid arthritis and chronic obstructive pulmonary disease.

The company said data indicate these medications are used by up to three out of every 100 adults over age 50 and approximately 50 percent of those prescribed chronic glucocorticoid therapy will eventually have an osteoporotoic fracture.

Lilly said a clinical study showed that in patients with GIO, Forteo increased bone mineral density from baseline to 18 months of treatment by 7.2 percent at the lumbar spine, 3.6 percent at the total hip and 3.7 percent at the femoral neck. Forteo acts by stimulating bone formation.

RTI International, a nonprofit research organization, is conducting the registry study for Lilly, which is part of its post-marketing obligation. Information will be collected from patients one time only and each year for 12 years the information will be linked to participating state cancer registries that obtain information on newly diagnosed cases of cancer. A Lilly spokesperson said the company does not have an estimated date for submitting data to FDA.

Registries Set Up For Fibromyalgia Drugs

Lilly has some experience in registries, which FDA is increasingly requesting to access pediatric use of products (see ² Also see "Registries Rising: FDA Looking At TNF Inhibitors; AHRQ Updates Standards" - Pink Sheet, 24 August, 2009.).

On July 31, Lilly launched a prospective, observational pregnancy registry for Cymbalta (duloxetine). FDA asked Lilly to implement the voluntary registry when the drug was approved for the additional indication of fibromyalgia in June 2008. The registry collects data from women who have taken the drug during their pregnancy. Similar registries are in place or are being implemented for Pfizer's Lyrica (pregabalin) and Forest Labs' Savella (milnacipran), which are also approved for fibromyalgia.

Forteo, a recombinant human parathyroid hormone, had worldwide sales of $778.7 million in 2008. Its expanded indication comes as a host of other players are seeking to elbow into the osteoporosis market (³ Also see "After D-mab: Next-Generation Osteoporosis Drugs Focus On Building Bone" - Pink Sheet, 3 June, 2009.). Since 2002, more than 500,000 patients worldwide have received Forteo.

- Brenda Sandburg ( ⁴ b.sandburg@elsevier.com )

Lilly Gains New Indication For Forteo, But Also A REMS And Patient Registry

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