Milestone Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application for the etripamil nasal spray, branded in Europe as TACHYMIST™. The acceptance is a pivotal regulatory step that moves the drug closer to commercial availability in the European Union, where it would become the first self‑administered nasal spray for acute paroxysmal supraventricular tachycardia (PSVT).
The EMA’s standard review process typically takes about 210 days, excluding clock stops for questions and responses. With the acceptance now in place, the company expects a final decision from the European Commission in the first quarter of 2027, aligning with the agency’s typical timeline. This timeline is critical because it determines when the company can begin sales and marketing activities in a market that represents a significant portion of its addressable patient base.
Europe is estimated to have roughly two million patients who could benefit from a rapid, self‑administered treatment for PSVT. By securing EMA acceptance, Milestone opens a new revenue stream that could transform its financial profile, which has historically been characterized by net losses and no product revenue. The company’s Q4 2024 results showed a net loss of $12.4 million, and its full‑year 2024 loss was $41.5 million, with no revenue from product sales. The EMA acceptance therefore represents a potential turning point in the company’s commercial trajectory.
Milestone’s CEO, Joseph Oliveto, emphasized that the acceptance “incorporates the global clinical data package that supported the U.S. FDA approval of etripamil for PSVT.” He added that TACHYMIST “could become the first approved patient self‑administered therapy representing a meaningful step forward in patient care for the approximately two million people suffering from PSVT in Europe.” These comments highlight the company’s confidence that the regulatory milestone will translate into a tangible market opportunity.
Beyond PSVT, the company is advancing etripamil in a Phase 3 program for atrial fibrillation with rapid ventricular rate (AFib‑RVR). The EMA acceptance strengthens the overall pipeline and could accelerate future approvals for this additional indication, further expanding the drug’s potential market. The company’s launch preparations are reportedly well underway, with resources secured to make the product available to patients and healthcare providers mid‑year, assuming final approval is granted.
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