March 22, 2023
Latest FDA Approvals for Biocom California Members
Latest FDA Approvals for Biocom California Members
A timely update on the latest drug approvals received by Biocom California member companies from the U.S. Food and Drug Administration (FDA) from December 2022 through March 2023.
Coherus BioSciences Granted Approval for Udenyca Autoinjector for Post-Chemotherapy
The Bay Area company received FDA approval in March for the single-dose, prefilled autoinjector presentation of Udenyca, a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the chances of infection. The company says it is the only pegfilgrastim therapy delivered in an autoinjector, which has a streamlined, easy-to-use design for both at the doctor’s office and at home. “There are certain types of cancer patients, those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device,” Dr. Lee Schwartzberg, chief of medical oncology and hematology at the William N. Pennington Cancer Institute and professor of clinical medicine at the University of Nevada, said in a statement.
First Oral Treatment for Anemia Caused by Kidney Disease is Now Available
More than 500,000 people in the U.S. have a chronic kidney disease that requires dialysis, which can lead to the body not producing enough red blood cells. The agency approved GlaxoSmithKline’s Jesduvroq tablets (daprodustat) as the first oral treatment for anemia caused by chronic kidney disease specifically for adults who have been receiving dialysis for at least four months. The approval was announced in February.
Sanofi’s Adacel Vaccine Approved to Prevent Pertussis in Infants During Pregnancy
The agency approved Adacel, a vaccine for tetanus, diphtheria and pertussis (Tdap), to be administered during the third trimester of pregnancy to prevent pertussis (whooping cough) in infants. Developed by Sanofi, Adacel is FDA-approved for active booster immunization against Tdap for people ages 10 through 64, and was the first vaccine globally to have a licensed indication for use in pregnancy to help prevent pertussis in young infants. According to the CDC, whooping cough is highly contagious and one-third of infants who contract it require hospital care. “We are pleased to receive the FDA’s approval for use of Adacel vaccine specifically during pregnancy to help protect young infants against pertussis, a potentially life-threatening disease,” Dr. Michael Greenberg, North America medical head of vaccines at Sanofi, said in a statement. “We pursued the label expansion to align fully with the long-standing health agency recommendations to provide Tdap vaccination to every woman in every pregnancy. We hope for higher and higher rates of Tdap vaccination in pregnancy so that fewer and fewer infants are likely to get pertussis.”
Leqembi Received Accelerated Approval for Treatment of Alzheimer’s
Alzheimer’s is a progressive brain disorder for which there is no cure. A new drug developed by Japan-based Eisai R&D Management Co. Ltd., Leqembi (lecanemab-irmb), is showing promise in clinical trials as a treatment for patients experiencing mild cognitive impairment or who are in the mild dementia stage of the disease. The medication was granted approval through the agency’s Accelerated Approval pathway, under which the FDA says it may approve drugs for serious conditions “where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.” In one study, patients receiving 10 milligrams of Leqembi every two weeks had significant reduction in brain amyloid plaque.
Gilead’s New Class of Anti-Retroviral Medication for Adults with HIV
In December, the FDA approved Sunlenca, the first in a new class of drugs to treat HIV-1 called capsid inhibitors. Developed by Gilead Sciences, Sunlenca is for HIV patients who experience resistance or intolerance to other HIV medications. It works by blocking the HIV-1 virus’ protein shell (the capsid), and first administered as an oral tablet followed by subcutaneous injections. Debra Birnkrant, M.D., director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement that Sunleca’s approval “ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options. The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”
Agency Approved Ferring’s First Gene Therapy for Bladder Cancer
Bladder cancer is the sixth-most common type of cancer in the U.S., and non-muscle invasive bladder cancer makes up almost 75 percent of these cases. Some patients with an aggressive form of the disease may need to undergo surgery to have the bladder removed. Switzerland-based Ferring Pharmaceuticals developed Adstiladrin, the first gene therapy for this type of bladder cancer, which the FDA approved in December. Adstiladrin is a non-replicating adenoviral vector-based gene therapy administered in the patient’s bladder once every three months. The company says Adstiladrin is expected to be available in the U.S. in the second half of this year.