- Radius Health disclosed Friday morning that the Food and Drug Administration has delayed a decision on approval of the Waltham, MA-based biotech's osteoporosis drug by three months.
- The FDA pushed its target action date back to June 30 from the previously expected March 30 in order to review additional information Radius submitted in response to FDA questions.
- Radius CEO Bob Ward, speaking on a call with analysts Mar. 10, said the extension was not related to manufacturing or supply chain issues, an area that has tripped up more drugmakers in recent quarters than in previous years.
Radius had been gearing up for a market launch of the drug, known as abaloparatide, in anticipation of a March approval, with onboarding and training for its U.S. salesforce nearing completion.
The FDA's decision to extend its review comes as a surprise, particularly given the nearness of the originally expected action date. Shares in Radius fell by more than 10% in Friday morning trading on the news.
On the Mar. 10 call, Radius CEO Bob Ward didn't give much more detail on what additional information the FDA had requested, but did rule out manufacturing issues.
"There is nothing that is new along manufacturing or supply chain related to this particular extension," Ward said. He did indicate, however, that Radius was continuing in labeling discussions with the FDA, which analysts seized on as a possible clue to the content of the discussions between the company and the regulator.
Radius believes abaloparatide, if approved, can steal market share away from leading products in the space, such as Eli Lilly's once-daily Forteo (teriparatide) and Amgen's twice-yearly Prolia (denosumab). The current New Drug Application from Radius pertains to a once-daily subcutaneous version of abaloparatide, but a transdermal patch is in Phase 2 testing.
Both versions are aimed at an indication for treatment of postmenopausal women with osteoporosis, a population Radius believes still has high unmet medical needs.
The delay of the FDA's approval decision is certainly a setback, but Radius' CEO remains optimistic the FDA may complete its review of the additional information before the full three-month period is complete.