FDA Approves Abaloparatide for High Risk Patients Save

On April 28th the Food and Drug Administration (FDA) approved abaloparatide (trade name Tymlos) for postmenopausal women with osteoporosis at high risk for fracture due to a history of osteoporotic fracture.  High Risk patients are defined as those with a history of prior osteoporotic fractures, multiple risk factors for fracture, or those unable to take other osteoporosis agents.  (Package insert: http://buff.ly/2pouOOP)

Medscape has reviewed this anabolic agent.  It is intended for high risk postmenopausal women with osteoporosis and is given as a daily 80 μg subcutaneous injection (usually admnistered in the periumbilical region). 

FDA approval is based on results the 18 month ACTIVE trial that included > 2000 women, subcutaneous and showed an 86% reduction in vertebral fractures and 43% reduction nonvertebral fractures.

The product label contains a boxed warning noting that the drug caused a dose-dependent increase in the incidence of osteosarcoma in rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-μg dose. Whether abaloparatide will cause osteosarcoma in humans is unknown.

Abaloparatide is contraindicated in those with osteosarcoma, Paget's disease, unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external-beam or implant radiation therapy to the skeleton.

As with Forteo (teraparatide), there is a 2 year lifetime limit on use because of these unknown risks. 

Abaloparatide will be available in the United States in June 2017.