The Food and Drug Administration on Thursday approved Regeneron Pharmaceuticals' Otarmeni, marking the first gene therapy approved for genetic hearing loss. The treatment targets a rare form of congenital deafness and represents a significant medical milestone in genetic therapies.

The FDA approval was announced alongside a broader drug pricing agreement between Regeneron and the Trump administration. Under the deal, Regeneron committed to lowering prices on all current and future drugs for Medicaid patients and agreed to sell its cholesterol medication Praluent for $225 through the administration's discounted drug website.

As part of the agreement, Regeneron will make Otarmeni available at no charge to clinically eligible individuals in the United States. The gene therapy received expedited approval through the FDA's Commissioner's National Priority Voucher program, which has faced scrutiny from congressional Democrats who note that vouchers have frequently gone to companies agreeing to White House pricing concessions.

The pricing deal represents the final agreement in a series of negotiations between the Trump administration and 17 major pharmaceutical companies. President Trump announced the Regeneron agreement at a White House event, calling it part of his administration's most-favored-nation initiative aimed at bringing U.S. drug prices in line with other developed nations.

Regenelon also committed to investing $27 billion in research, development and manufacturing in the United States as part of the agreement. The company has a notable history with Trump, having provided him with an experimental antibody treatment during his COVID-19 hospitalization in 2020.

While the administration has touted these drug pricing deals as transformative, the complete details of the agreements have not been made public. Health Secretary Robert F. Kennedy Jr. has indicated his department will share whatever contract details it can without revealing proprietary information or trade secrets.