FDA approved Tymlos (abaloparatide) for Osteoporosis in Postmenopausal Women and MenFDA approved new drug Tymlos to treat osteoporosis in high-risk patients

Tymlos is a human parathyroid hormone related peptide [PTHrP(1-34)] analog. It is not specified in the label, but it is known to have anabolic effects on bone.

Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. It is also indicated to increase bone density in men with osteoporosis at high risk for fracture, or who have failed or are intolerant to other available osteoporosis therapy.

The recommended dosage is 80 mcg subcutaneously once daily. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Administer into the periumbilical region of the abdomen, rotating the injection site daily. Administer at approximately the same time each day. Do not administer intravenously or intramuscularly. The first several doses should be administered where the patient can sit or lie down if symptoms of orthostatic hypotension occur. Visually inspect the solution before use; it should be clear and colorless. Do not use if particulate matter or discoloration is present. Treatment duration should not exceed 2 years during a patient's lifetime.

In an 18-month randomized, double-blind, placebo-controlled trial (Study 003) in postmenopausal women (mean age 69), Tymlos 80 mcg daily (N=824) compared with placebo (N=821) significantly reduced the incidence of new vertebral fractures: 0.6% vs 4.2% (p<0.0001), an absolute risk reduction of 3.6% and relative risk reduction of 86%. The trial also included a 6-month open-label extension with alendronate, showing sustained fracture risk reduction at 25 months. Trial data for men were not available in the label.

Orthostatic hypotension may occur, especially after the first several doses; administer where the patient can sit or lie down. The safety and efficacy beyond 2 years have not been evaluated; use for more than 2 years is not recommended. No other warnings or contraindications were provided in the label.

Tymlos is an anabolic agent for patients with osteoporosis at high risk for fracture or those who have failed or are intolerant to other therapies. It is an option for both postmenopausal women and men. The label notes that it reduces vertebral and nonvertebral fractures in postmenopausal women. It is administered subcutaneously daily, with a maximum treatment duration of 2 years.