Johnson & Johnson’s Covid-19 vaccine accounts for about 3% of total U.S. doses, well behind Pfizer/BioNTech and Moderna’s vaccines.A year after safety concerns led to the addition of a warning to the emergency authorization of a vaccine, the FDA is further revising the authorization to Limit who can catch the ball.
Authorization of the Johnson & Johnson Covid vaccine now covers only adults who cannot or cannot obtain other approved or authorized vaccines.Last year, the FDA suspends dosing of authorized Johnson & Johnson vaccine as it investigates reports of blood clotsThe FDA said its latest revision to the authorization follows a review of the rare but potentially serious risk of blood clots and low platelet levels that can occur within two weeks of dosing. FDA officials said the changes it made to the authorization reflect its latest analysis of those risks.
In non-Covid news, some drugs were approved in the U.S. and Europe, while some biotechs faced setbacks in their drug development plans. Below is a review of regulatory decisions and clinical trial progress over the past week.
Regulatory Approval
—Enhertu, a breast cancer drug that received accelerated FDA approval in 2019 As a treatment for advanced HER2-positive breast cancer, the agency’s fully approvedThe decision was based on positive results from a phase 3 study that showed the drug reduced the risk of disease progression or death by 72% compared to trastuzumab emtansine. Enhertu was developed by partners AstraZeneca and Daiichi Sankyo. The drug is an antibody-drug conjugate, a drug that links a toxic killer drug payload to a targeting antibody.
– Orphalan wins FDA Approve Curivor, a treatment for Wilson disease. This rare genetic disorder causes excess copper to be stored in various tissues of the body. Paris-based Orphalan has commercialized the drug in Europe, where it is marketed under the name Cuprior.
– Supernus Pharmaceuticals won Additional FDA Approval For its attention-deficit hyperactivity disorder drug Qelbree, its use in adults is covered.Regulatory nod comes nearly a year after the drug hits the market Originally approved to treat ADHD in children ages 6 to 17.
– Incyte drug Jakavi has a Newly Approved Indications in Europe. The European Commission approved the product for the treatment of acute graft-versus-host disease in patients 12 years of age and older who have not responded to earlier treatment regimens. Jakavi is marketed in the United States as Jakafi and belongs to a class of drugs called JAK inhibitors. U.S. approvals for the product include graft-versus-host disease, polycythemia vera, and myelofibrosis. The drug is marketed in Europe by partner Novartis.
– Phatham Pharmaceuticals wins FDA Approved a new drug treat infection Helicobacter pylori, a bacterial pathogen that affects an estimated 115 million people in the United States Phatham’s drug Voquenza consists of the novel acid-blocking compound vonoprazan. Acid suppression has been part of H. pylori treatment to increase the effectiveness of antibiotics. Regulatory approval covers two blister pack products containing Vonorazan. One is a blister pack containing capsules of the antibiotics amoxicillin and clarithromycin, and the other contains capsules of amoxicillin only. Phatham acquired the rights to vonoprazan from Takeda Pharmaceuticals.
wait, not so fast
— Praxis Precision Medicines disclosed in a report Regulatory filing The FDA sent an email notifying the company that it had placed its clinical hold Regarding the company’s Investigational New Drug Application for PRAX-222, an antisense oligonucleotide that the biotechnology company is developing to treat a form of epilepsy. A formal letter with details of FDA questions or concerns is expected within a month.
-A sort of clinical hold Placed in Phase 1/2 study evaluating Vertex Pharmaceuticals’ cell therapy in type 1 diabetesVX-880 has been well tolerated by patients so far, with no serious adverse events reported, according to the Boston company. But Vertex said the FDA told the company that “there is insufficient information to support a dose escalation for this product.”
-A sort of Partial clinical hold placed in a study evaluating BioCryst Pharmaceuticals’ drug candidate BCX9930, An experimental oral therapy for the rare blood disorder primary nocturnal hemoglobinuria. The company voluntarily suspended enrollment in the study in early April to investigate higher levels of the enzyme as an indicator of kidney problems.
don’t go to FDA
— The FDA rejected Axsome Therapeutics’ New Drug Application for AXS-07, which is used to treat acute migraine. Axsome said the agency’s complete reply letter Noting issues with chemistry, manufacturing and controls, the New York-based biotech company recently Regulatory filing. Axsome said the issues are fixable and the company plans to resubmit after speaking with the FDA.
– The FDA also rejected the drug From Hutchison Medical and partners Junshi Biosciences and Coherus Biosciences. Submissions for Hutchmed’s drug surufatinib, developed to treat neuroendocrine tumors, and the Junshi/Coherus drug toripalimab, an immuno-oncology drug for nasopharyngeal cancer, are based on data primarily from clinical trials conducted in China.refuse to follow complete reply letter Cancer drug sent to Eli Lilly and Innovent, which was tested in China. The FDA said it expects regulatory submissions to include clinical data from multiple regions, although the Junshi/Coherus letter specifically identified “quality process changes” that the company believes could be easily addressed.
– Zosano Pharmaceuticals has pause Its M207 program is a formulation of the migraine drug zolmitriptan, which is administered via microneedling on a skin patch. The FDA previously rejected the company’s drug application, citing inconsistent drug exposure levels in clinical studies. Although the FDA allowed Zosano to resubmit its application for another year, the biotech chose to suspend the program to preserve cash. March, Zosano implements corporate restructuring, lays off 31% of staff, and begins exploring strategic alternatives.
Food and Drug Administration photo
