Avenacy launches generic DDAVP for bleeding in mild hemophilia A
Single-dose vials are to be administered by injection
A generic version of DDAVP (desmopressin acetate), a therapy approved to control bleeding episodes in people with mild hemophilia A, is available in the U.S.
Avenacy planned to begin shipping the therapy the week of April 15, according to a company press release.
The generic is available under the name Desmopressin Acetate for Injection. It is supplied in single-dose vials that contain 4 micrograms (mcg) per 1 mL of solution or multiple-dose vials of 40 mcg in 10 mL of solution. Like the brand name medication, the generic is designed to be administered by intravenous (into the vein) or subcutaneous (under-the-skin) injection.
Generic medicines contain the same active ingredient and are expected to provide the same benefits of the approved brand-name medicines, or reference products, on which they are based. Generics may be sold after the patent granting marketing exclusivity to the reference product, in this case, Ferring Pharmaceuticals’ DDAVP, has expired.
Generic treatments are usually priced lower than brand-name therapies, since their developers do not need to conduct preclinical and clinical studies to demonstrate the therapies’ safety and efficacy for certain indications.
Hemophilia A is caused by mutations in the F8 gene that lead to the lack or dysfunction of clotting factor VIII (FVIII), a protein involved in blood clotting. A deficiency in FVIII puts hemophilia A patients at increased risk for excessive and prolonged bleeding episodes that can happen spontaneously or after an injury or trauma.
The disease is typically treated with replacement therapies that provide patients with a working version of the FVIII protein to improve blood clotting.
Therapy can also be used for von Willebrand disease
Desmopressin is a lab-made version of vasopressin, a naturally occurring hormone that stimulates the release of clotting factors, including FVIII and von Willebrand factor (vWF), a protein that transports and stabilizes FVIII in the bloodstream.
Like DDAVP, the new generic is indicated for reducing spontaneous or trauma-induced bleeding in people with mild hemophilia A (FVIII activity levels above 5% of normal) and without FVIII inhibitors, neutralizing antibodies that can lower the effectiveness of standard replacement therapies. It is also indicated to prevent bleeding during and after surgical procedures in these patients.
The therapy can also be used to treat people with Type 1 von Willebrand disease, which is caused by low levels of functional vWF, and those with diabetes insipidus, a condition marked by an imbalance of bodily fluids that can cause excessive thirst and production of large amounts of urine.
One of the treatment’s possible side effects is hyponatremia, or abnormally low levels of sodium in the bloodstream, a condition that may be life-threatening. Sodium helps regulate the amount of water in the body, so patients’ blood sodium levels should be monitored before and during treatment. In the presence of hyponatremia, treatment with desmopressin should be temporarily or permanently suspended.
Other generic versions of the therapy are available in the U.S., including one launched by Dr. Reddy’s Laboratories in 2020.
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