FDA approves Abaloparatide, the first anabolic treatment for postmenopausal osteoporosis.

Courtesy: Radius Health 

The US Food and Drug Administration (FDA) approved abaloparatide injections for treatment of postmenopausal women who are at high risk for developing osteoporosis. It is marketed under brand name TYMLOS.

It is the first anabolic treatment approved for women at risk of osteoporosis in last 15 years said the company Radius Health.

1. It is indicated in women with history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
2. The recommended daily dose of Tymlos is 80 mcg subcutaneously into the periumbilical region of the abdomen.
3. Women should supplement the diet with Calcium and Vitamin D.
4. Its use in combination with parathyroid hormone for more than 2 years is not recommended.  
5. It is available as prefilled pen with 30 doses of the drug as sterile, clear, colorless solution.

The clearance of abaloparatide was based on the positive results of a phase 3, multicentric, randomized, double-blind, placebo controlled trial called as Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial and also ACTIVExtendTrial.

 The ACTIVE trial recruited nearly 2500 women postmenopausal women with osteoporosis aged 49 to 86 years (mean age 69 years) who were randomized to receive 80 mcg of TYMLOS (N = 824) or placebo (N = 821), given subcutaneously once daily for 18 months.

The ACTIVE trial showed that patients on abaloparatide had 86% reduced risk of new vertebral fractures and 43% reduction for nonvertebral fractures. The absolute risk reduction was 3.6% and 2.01% respectively.

The paper was published in April 2016 issue of JAMA.

The ACTIVExtend Trial is an extension of the previous trial recruited patients who has already completed 18 months of subcutaneous abaloparatide or placebo. They received up to 24 additional months of alendronate; there was 1 month between the studies to re-consent patients.

The study results published in Mayo Clinic Proceedings showed improvement in bone mineral density and reduced fracture risk throughout the skeleton.

The label on abaloparatide shows a boxed warning about a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-mcg dose. It is unknown if abaloparatide will cause osteosarcoma in humans.

It is contraindicated in patients at increased risk of for osteosarcoma and its cumulative use with parathyroid hormone analogs (eg, teriparatide) for more than 2 years during a patient's lifetime is not recommended.

John Bilezikian, MD, director of the metabolic bone diseases program at Columbia University Medical Center in New York City, said in a company news release "Provides physicians a new treatment option for postmenopausal women with osteoporosis which could help to rapidly, consistently and significantly increase bone mineral density and reduce their risk of fractures. Fragility fractures should be viewed as sentinel events which require urgent evaluation and treatment because after that first fragility fracture, patients are at greater risk for subsequent fractures. The FDA's approval of Tymlos represents an important step in our ability to treat this serious and complex disease and, in the process, address this urgent public health crisis."