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Re: CantorFitzgerald Price target $40 love these lofty targets and the failure rates they come with. Slightly better than half of that would be a huge win, $18-22 is closer to what a chart would say, and that falls in line with what should be an expected pull back as true investors (not biased permabulls) wait for real data on adaptation and revs. The future of stem cell transplants could have an impact some day on all 12 drugs approved for rMS to date. FDA Clears Twice a Year Monoclonal Antibody for MSUblituximab, now with brand name Briumvi, is the first anti-CD20 monoclonal antibody approved for patients with multiple sclerosis that can be administered in a one-hour infusion twice-a-year. The FDA has approved TG Therapeutic’s Briumvi (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS). Briumvi is the first anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be administered in a one-hour infusion twice-a-year following the starting dose. “Over the past several years we have seen a dramatic shift in the MS treatment landscape toward the use of B-cell therapy, which has shown to be highly effective in reducing relapses in patients,” Lawrence Steinman, M.D., Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University, said in a press release. “This approval is great news for patients living with MS and provides an appealing treatment alternative that can be administered in a one-hour infusion twice-a-year following the starting dose, which I believe is an added benefit to patients.” TG Therapeutics expects to launch Briumvi in the first quarter of 2023. The company didn’t release pricing information but a recent evidence report from the Institute for Clinical and Economic Review (ICER) found multiple sclerosis therapies are not considered cost-effective and would have to be discounted by 51% to 84%. Related: ICER: Monoclonal Antibodies Not Cost-Effective in Multiple Sclerosis The FDA’s approval was granted for based on data from the ULTIMATE I & II phase 3 trials Both trials met their primary endpoint with statistically significant reduction in annualized relapse rate over a 96-week period compared with Sanofi’s Aubagio (teriflunomide) in patients with relapsing multiple sclerosis. ULTIMATE I and II demonstrated significant reductions in risk of relapses, as well as reduction of active or new brain lesions. In a pooled analysis the most common adverse event associated with Briumvi was infusion related reactions (47.7% of patients who received Briumvi experienced at least one infusion-related reaction vs. 12.2% for the teriflunomide group). ICER analysts used a placeholder price of $55,081 for Briumvi, which is equal to the net price of Genentech’s Ocrevus (ocrelizumab). ICER analysts had higher certainty that Briumvi provides a small net health benefit over Aubagio. But they said Briumvi — as well as Biogen’s Tysabri (natalizumab), Novartis’ Kesimpta (ofatumumab), and Ocrevus — would all have to be priced at between $16,500 and $34,900 per year to be considered cost-effective. ICER’s analysis will be reviewed at a Jan. 20, 2023, meeting. Tuesday, January 7, 2020 New multiple sclerosis treatment trial compares stem cell transplantation to best available drugsNIH-funded study focuses on severe forms of relapsing MS. |
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