Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
RSV jab race comes to an end
After a years-long heated race for approval — with juggernauts like Pfizer, GSK and Sanofi all neck and neck chasing the first FDA stamp — we have a winner.
In November 2022, GSK received Priority Review for its RSV vaccine candidate in older adults — giving the drugmaker a leg up with a regulatory action date of May 3, 2023. Earlier this week, we reported that the FDA had approved its RSV jab — to be sold as Arexvy — for preventing lower respiratory tract disease (LRTD) in individuals 60 years of age and older, marking the first-ever RSV vaccine for older adults to be approved globally.
GSK’s jab was granted its designation based on results from the AReSVi-006 phase 3 trial, which showed high overall vaccine efficacy against RSV lower respiratory tract disease in adults aged 60 years and older. In early March, an FDA advisory panel voted unanimously 12-0 on the vaccine's effectiveness and 10-2 on safety, teeing the candidate up for approval.
Close behind is Pfizer, who is also awaiting a U.S decision this month. Back in December, the drugmaker announced that it had received Priority Review for its vax candidate, RSVpreF, which had also been granted Breakthrough Therapy designation earlier last year. The designation shortened the review period by four months, granting RSVpreF a May 31 PDUFA date.
RSV vaccines present a highly profitable new market opportunity for companies. Analysts have estimated that the market for RSV vaccines to surpass $10 billion by 2030, and Credit Suisse analysts have said that GSK's jab could surpass $2.5 billion in peak sales.
Move over COVID, there's a new vax in town.
— Andrea Corona
The antibiotics conversation hits the Hill
Me again, still talking about antibiotics — and I'm excited that the conversation has once again reached Congress.
As I previously discussed, last month, GSK shared positive results from two phase 3 trials for gepotidacin, an investigational antibiotic for uncomplicated urinary tract infections — bringing the drugmaker a step closer to having the first in a new class of oral antibiotics for the indication in over 20 years. Shortly after, an FDA advisory committee voted to support the approval of Innoviva's intravenous antibiotic for the treatment hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The treatment, sulbactam-durlobactam, combats life-threatening Infections caused by the drug-resistant pathogen, Acinetobacter.
The latest update is that senators Michael Bennet (D-CO) and Todd Young (R-IN) and representatives Drew Ferguson (R-GA) and Scott Peters (D-CA) have reintroduced a key piece of legislation — the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act — in Congress.
An article I authored last year (which, shameless plug, was a Neal Award finalist for 'best single article') focused on this bipartisan, bicameral legislation — which, despite building momentum, keeps struggling to get through Congress.
If finally passed, the law would change the way the U.S. government pays for critically needed antimicrobials, basing it on value to public health, not sales volume. Under PASTEUR, developers would appeal to a HHS committee to have their drugs designated as ‘critical need antimicrobials’ — a criteria that would be defined within the bill and updated to reflect changing resistant threats. Developers who qualify would be eligible for contracts ranging from $750 million to $3 billion, over 5-10 years.
It's a strong bill with a lot of support. But the real game-changer lies in the global message the U.S. would send by passing it: The antibiotics market is viable, profitable and no longer ablaze.
—Karen Langhauser
