Oncopeptides AB is voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company disclosed on Oct. 22. The FDA gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. The company said that the decision follows the Phase III OCEAN study, which “the FDA does not consider…meets the criteria of a confirmatory study.” In July, the FDA issued an alert about the trial results showing “an increased risk of death” for people on Pepaxto plus dexamethasone compared with Bristol Myers Squibb unit Celgene Corp.’s Pomalyst (pomalidomide) in combination with dexamethasone. Oncopeptides will “refocus” on being a Sweden-based research-and-development firm concentrating on developing its proprietary Peptide Drug Conjugate platform and will shut down commercial business units in the U.S. and Europe, as well as “significantly” reduce its Stockholm-based organization.
In 2010, an average Medicare Part D plan covered 73% of prescribed drugs, but in 2021, the average plan covered only 55% of prescribed therapies, according to a report by GoodRx. The company analyzed 3,707 plans and their coverage from 2010 to 2021. Researchers also found that 27% of drugs in 2010 had some kind of insurance restriction, such as step therapy or prior authorization, a percentage that rose to 47% in 2021. In addition, patients’ out-of-pocket costs are rising as well. Over the last 10 years, the average deductible increased from $917 to $1,644. In addition, the average copay or coinsurance for the highest formulary tier in 2010 was $677, but in 2019, it was $2,211. The report noted that the commercial insurance market usually reflects the trends occurring in Medicare.
The FDA, National Institutes of Health (NIH), 10 pharmaceutical firms and five nonprofits have launched the Bespoke Gene Therapy Consortium (BGTC), an initiative aimed at speeding up the development of gene therapies for the 30 million Americans who suffer from about 7,000 rare diseases. The BGTC is part of the NIH Accelerating Medicines Partnership program and is project managed by the Foundation for the National Institutes of Health. One of the main goals is to improve understanding of the adeno-associated virus, a common gene delivery vector. The BGTC will develop standard analytic tests for the manufacture of viral vectors with an eye on making gene therapy development for rare conditions more efficient. NIH and the private partners will contribute about $76 million over five years to the effort.
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