The FDA made an announcement that it will not take any action on the use of Phathom’s Voquezna for erosive esophagitis by its intended action date after recent tests found trace quantities of a potential carcinogen in commercial batches of the medication.
Regulatory setbacks continue as Phathom Pharmaceuticals approaches the one-year anniversary of Voquezna’s FDA clearance to treat Helicobacter pylori infection.
Phathom reported receiving complete response letters (CRLs) from the FDA for both its active drug application for erosive esophagitis and its post-approval supplement for its H. pylori licence.
According to the New Jersey-based company, the letters formalise the FDA’s request for Phathom to produce further data demonstrating that levels of a potentially cancer-causing chemical in the medication will consistently stay at or below the daily allowable consumption limit of 96 nanograms.
Voquenza’s release has been postponed in the drug’s approved usage in the meantime. The business anticipates meeting with the FDA to go over a resubmission plan and timetable. According to the company, this strategy will result in the approval and commercialization of products containing vonoprazan.
A representative of Phathom said:
“The CRLs aren’t expected to weigh heavily on the company’s business overall. Our cash position is strong, and no layoffs are planned based on the issuance of the CRLs. We continue to work closely with the FDA and look forward to making vonoprazan available to patients as soon as possible.”
The company claims to have made all the necessary background checks in terms of impurity’s root source and implemented mitigation strategies. This will guarantee that the medicine stays within the FDA threshold.
With vonoprazan, Phathom won the regulatory battle three years after its split from Takeda. For the treatment of H. pylori infection, which generally affects the stomach or small intestine, the FDA approved vonoprazan in two combinations. The antibiotic amoxicillin is combined with the innovative potassium-competitive acid blocker vonoprazan in the Voquezna Dual Pak, and clarithromycin is added in the Voquezna Triple Pak. The medications were initially scheduled for sale in the market in the third quarter of 2022 by Phathom.
Takeda has previously started offering the treatment in a number of Asian countries.
However, the company stated that nitrosamine testing detected trace quantities of the contaminant in the recently authorised medication shortly after the FDA approval. In other places, nitrosamines have recently caused a lot of trouble for medicine manufacturers. The substances, which are present in commonplace things like food and water, have led to significant product recalls, shortages, and pulls across the sector.
Phathom is not alone in these problems as three of the biggest names in biopharma had to deal with contaminants in their medicines in August 2022 as well.
Numerous lawsuits were filed against Sanofi and GSK as well as GSK’s consumer spinoff Haleon due to the cancer-causing contaminant N-nitroso dimethylamine (NDMA) found in goods containing ranitidine. Zantac, the most well-known ranitidine medication, is manufactured by Sanofi and was first created by GSK. The FDA raised concerns about nitrosamine contaminations in some batches of sitagliptin, the active ingredient of Merck’s well-known type 2 diabetes medication Januvia. The manufacturer of the sitagliptin-containing diabetic medications Januvia, Janumet, and Steglujan confirmed the existence of NTTP in selected batches of the medication.