FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022

2023-01-03

上市批准加速审批

The Food and Drug Administration’s main office for reviewing new medicines cleared 37 in 2022, closing out the year with approvals of treatments for HIV, lymphoma and multiple sclerosis.

The total was the lowest number since 2016, when the FDA’s Center for Drug Evaluation and Research granted 22 approvals, and was well below last year’s figure of 50. The center, known as CDER, approves most pharmaceutical treatments, as well as common biologic drugs like monoclonal antibodies.

While calendar year totals can fluctuate for many reasons, they are sometimes looked to as a shorthand value of the industry’s research and development productivity. Another FDA office, the Center for Biologics Evaluation and Research, is responsible for clearing more complex biologic drugs like vaccines, cell and gene therapies, and approved seven new medicines in 2022.

CDER’s final decisions of last year included Dec. 22 approvals for Gilead Sciences’ Sunlenca, for people with drug-resistant HIV, and Roche’s Lunsumio, for relapsed or refractory lymphoma. The agency approved TG Therapeutics’ Briumvi for relapsing multiple sclerosis on Dec. 28, as well as a treatment for thermal burns.

Sunlenca and Lunsumio, in particular, were anticipated approvals for their respective makers. Both had previously been cleared for marketing in Europe.

Given twice-yearly, Sunlenca is a first-of-its-kind drug that Gilead hopes can be used as both a treatment and preventive option for HIV. Its initial approval in the U.S. is for adults whose HIV infection can no longer be controlled by existing treatment regimens due to drug resistance, intolerance or safety reasons.

Approval was supported by results from a trial called CAPELLA, which showed treatment with Sunlenca, when added to an antiviral regimen, pushed viral loads down to undetectable levels in 81% of patients with multidrug-resistant HIV.

Sunlenca’s approval in the U.S. was held back by concerns about the potential for glass particles to form in vials of the drug that were made with borosilicate, leading to an initial FDA rejection in March. Gilead later switched vials.

Approval of Roche’s Lunsumio, meanwhile, marks another milestone, as it’s the first bispecific antibody approved by the FDA that targets proteins known as CD3 and CD20. A group of competitors from AbbVie, Regeneron and Johnson & Johnson is lining up behind Roche, and the dual-binding drugs are viewed as the next step forward in lymphoma treatment.

In the U.S., Lunsumio is cleared for adult patients with the most common slow-growing form of non-Hodgkin lymphoma who have previously received at least two systemic therapies. The FDA granted it an accelerated approval, meaning Roche must confirm its benefit in further clinical testing.

TG Therapeutics’ Briumvi also targets the CD20 protein, which is found on B cells, but is for the autoimmune disease multiple sclerosis. In clinical testing, treatment with the drug led to lower annualized relapse rates than Sanofi’s drug Aubagio, but didn’t significantly reduce the risk of worsening disability.

The FDA had previously delayed its decision on Briumvi to review additional information submitted by TG Therapeutics. The New York-based biotechnology company had sought to win approval of Briumvi’s active drug ingredient, called ublituximab, in combination with another medicine for two types of leukemia, but in April withdrew its application after disappointing clinical trial data.

New drug approvals by FDA's CDER office declined in 2022YearTotal CDER approvalsNotable drugs cleared202237Opdualag, Mounjaro, Relyvrio202150Lumakras, Aduhelm, Leqvio202053Zeposia, Evrysdi, Veklury201948Trikafta, Oxbryta, Enhertu201859Biktarvy, Onpattro, Vitrakvi201746Dupixent, Ocrevus, Hemlibra201622Tecentriq, Exondys 51, Spinraza201545Cosentyx, Ibrance, TagrissoSOURCE: FDA

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