On This Day in Health: April 28, 2017
On April 28, 2017, the U.S. Food and Drug Administration approved Tymlos, or abaloparatide, for postmenopausal women with osteoporosis who were at high risk of fracture. Radius Health developed the medicine, which was administered by subcutaneous injection. The approval added a treatment designed to build bone, offering a different approach from therapies whose principal effect is to reduce bone breakdown. Its original indication was specific to postmenopausal women meeting high-risk criteria. Later changes in a medicine’s approved uses should be kept separate from this 2017 event. The anniversary marks the first U.S. regulatory decision for the product and the evidence available at that time.
Osteoporosis weakens the skeleton and makes fractures more likely. Bone is living tissue, continually renewed through processes of formation and resorption. When those processes no longer maintain sufficient strength, injuries can occur after stresses that a healthier skeleton might withstand. The consequences can include pain, reduced mobility and loss of independence. A treatment intended to increase bone formation addresses one side of this balance. Its practical value, however, must be judged by clinical outcomes as well as by measurements of bone mineral density. A change on a scan is useful information, but preventing fractures is the outcome that gives the intervention its importance in everyday life.
The development program included ACTIVE, a randomized study of 2,463 postmenopausal women followed during an 18-month treatment period. The study compared abaloparatide with placebo and also included an active treatment group receiving teriparatide. Findings supporting the approval included fewer new vertebral fractures with abaloparatide than with placebo. The reported relative reduction was 86 percent, corresponding to an absolute difference of 3.6 percentage points. Nonvertebral fractures also favored treatment, with a reported relative reduction of 43 percent and an absolute difference of 2.0 percentage points. These are different ways of describing results from the study, and neither should be turned into a claim that every fracture could be prevented.
April 28 highlights how osteoporosis research moved beyond a simple picture of bones as inert structures. Understanding the biology of bone renewal made it possible to develop medicines aimed at formation, then test whether that approach reduced injury. The approval did not remove the need to consider adverse effects, treatment duration and the individual patient’s risk. It established another option within a larger field of bone health care. The milestone’s enduring significance is the connection between a biological strategy and evidence on fractures in a defined population. That connection makes the anniversary more than a product launch story: it records a step toward reducing the disabling consequences of skeletal fragility while keeping the scale and limits of the clinical findings clear.
Tymlos received FDA approval on April 28, 2017.
The original indication concerned postmenopausal women at high fracture risk.
Abaloparatide was developed as a bone-building treatment.
The ACTIVE study enrolled 2,463 women.
New vertebral fractures were reduced compared with placebo over 18 months.
Relative and absolute risk reductions describe different aspects of the study results.
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