Onco360 pharmacy to supply add-on Voydeya to PNH patients
Alexion picks pharmacy as national partner for EVH treatment
Onco360 will supply Voydeya (danicopan), an oral add-on medication for treating extravascular hemolysis (EVH), or red blood cell destruction occurring outside blood vessels, to adults with paroxysmal nocturnal hemoglobinuria (PNH).
Alexion Pharmaceuticals selected the pharmacy, a subsidiary of BrightSpring Health Services, as a national pharmacy partner.
“This is another highly specialized, first-in-class drug that will complement current treatment regimens, and we’re proud to be a trusted pharmacy and implement leading clinical and service practices for this drug and patients,” Benito Fernandez, Onco360’s chief commercial officer, said in a BrightSpring press release.
PNH is marked by the destruction of red blood cells (hemolysis) due to the abnormal activation of the complement cascade, a group of immune proteins.
Soliris (eculizumab) and Ultomiris (ravulizumab) are standard approved therapies that can help prevent hemolysis in people with PNH. Both medicines target C5, a complement protein, to stop the activation of the complement cascade.
Although these therapies can effectively reduce hemolysis occurring inside blood vessels, up to 20% of PNH patients on Soliris or Ultomiris continue experiencing EVH.
FDA approved Voydeya in April
The U.S. Food and Drug Administration (FDA) in April approved Voydeya as a first-in-class, add-on therapy to Ultomiris or Soliris to treat EVH in adults with PNH. The therapy is designed to target Factor D, a complement protein that acts before C5 in the cascade of complement activation. Voydeya is expected to help prevent EVH without interfering with the activity of Ultomiris or Soliris.
“This innovative drug from Alexion is a significant advancement in the treatment of PNH with EVH and will help improve the lives of those impacted by this disease,” said Jon Rousseau, president and CEO of BrightSpring.
Voydeya’s approval in the U.S. was supported by data from a Phase 3 clinical trial called ALPHA (NCT04469465), which evaluated the therapy in 86 adults with PNH with clinically significant EVH.
In addition to standard Ultomiris or Soliris, participants were randomly assigned to receive Voydeya at an initial dose of 150 mg, with the possibility of increasing to 200 mg, or a placebo for three months. All patients were then given Voydeya for approximately another three months. Those who completed the full six months had the option to enter a long-term extension phase and continue receiving Voydeya for two years.
Three-month data showed that, when compared with placebo, Voydeya significantly reduced the signs of EVH, as indicated by an increase in the levels of hemoglobin, the protein inside red blood cells that’s responsible for transporting oxygen through the bloodstream. The add-on therapy also reduced patients’ need for blood transfusions and eased their fatigue.
More recent data from ALPHA showed Voydeya’s ability to control EVH was sustained for almost a year. The most common side effects reported in ALPHA included headache, joint pain, nausea, and diarrhea.
“We are extremely proud of Onco360 for being selected as the preferred pharmacy for Voydeya, as it shows the company’s commitment to supporting cutting-edge treatment options the best possible way for patients living with cancer and complex diseases,” said Rousseau. “We commend their leadership in partnering with biopharmaceutical leaders to continually innovate the proven standard of care.”
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