Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
FDA second chances
This week, we saw two drugmakers betting on second chances: Roche is making a comeback with its neovascular or 'wet' age-related macular degeneration (nAMD) treatment, and Elevar is gearing up to resubmit its liver cancer drug.
On Monday, Roche announced the FDA approval of updates to Susvimo, a treatment for nAMD. Susvimo offers an alternative to regular eye injections by delivering medication continuously through a surgically implanted, refillable device needing only two refills a year.
Initially approved by the FDA in 2021, Susvimo was voluntarily recalled by Roche's Genentech the following year due to performance issues. The company has since updated the implant and refill needle to meet necessary standards.
Also this week, Elevar Therapeutics announced its plans to resubmit its FDA application for rivoceranib combined with camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC).
This decision followed a Type A meeting with the FDA on July 2, 2024, where the agency confirmed the resubmission could proceed without delay, with potential additional GMP and Bioresearch Monitoring (BIMO) inspections post-resubmission.
The original NDA, submitted in May 2023, received a complete response letter citing GMP deficiencies at Jiangsu Hengrui Pharma's facility and incomplete BIMO inspections due to FDA travel restrictions. There were no issues with clinical data or the rivoceranib manufacturing site. Elevar plans to resubmit promptly, including data from the CARES-310 study, which showed a median overall survival of 23.8 months for patients with uHCC.
While success rates for resubmissions can vary, many drugs eventually gain approval after companies provide additional data or make necessary modifications. The agency offers a structured path for resubmissions, often leading to successful approvals, especially if the initial concerns are adequately addressed.
And while the process can be lengthy and demands rigorous compliance, the alternative of a program failing is far worse. So, here’s to trying again. — Andrea Corona
FTC takes aim at PBMs
Earlier this week, the FTC released a long-awaited report on the prescription drug middleman industry, which included a not-at-all-favorable discussion of the impact PMBs have on the accessibility and affordability of prescription drugs.
The 73-page report is the result of a 2+ year probe into the country’s six largest PBMs. According to the FTC, “The insights gained thus far underscore the importance and urgency of scrutinizing the role and influence of PBMs in the nation’s health care system.”
Shortly after the report was published, the WSJ — in an exclusive story citing “a person familiar with the matter" — reported that the FTC is planning to sue UnitedHealth, Cigna and CVS Health over their tactics as middlemen in negotiating prices for drugs, including insulin.
The three companies own the country’s largest PBMs — OptumRx (UnitedHealth), Express Scripts (Cigna) and CVS Caremark (CVS Health). According to the WSJ, the companies’ PBMs are being investigated for the rebates — volume-based discounts — they negotiate with drug manufacturers.
(Of note: After years of drugmakers blaming PBMs for high drug prices, a CVS spokesperson turned the tables, telling Reuters that "Any action that limits the use of these PBM negotiating tools would reward the pharmaceutical industry and return the market to a broken state, leaving American businesses and patients at the mercy of the prices drugmakers set.")
While the current FTC chair Lina Khan has been critical of drugmakers, particularly in terms of M&As, PBMs have skated under the anticompetitive conduct radar, but it seems those days are now over. —Karen Langhauser
