August 17, 2023

Latest FDA Approvals for Biocom California Members

Latest FDA Approvals for Biocom California Members

An update on the latest drug approvals received by Biocom California member companies from the U.S. Food and Drug Administration (FDA) from April 2023 through August 2023.

New Pneumococcal Conjugate Vaccine for Infants and Children

Pfizer received approval for PREVNAR 20, a 20-valent vaccine that prevents invasive pneumococcal disease (IPD) in infants, children and young adults, in April. The vaccine can be administered to infants as young as six weeks old, and for teenagers through the age of 17. “Today’s FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children,” Annaliesa Anderson, Ph.D., Pfizer’s senior vice president and chief scientific officer of vaccine research and development, said in a release.

Biogen Makes Major Breakthrough for Treating ALS

In April, the FDA granted accelerated approval for Qalsody (tofersen), the first treatment that targets the genetic cause of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. Biogen collaborated with Ionis Pharmaceuticals on the early development of the treatment, which is administered via injection. Qalsody was shown in studies to reduce plasma neurofilament light chain (NfL) in patients, which is a marker of neurodegeneration.

Agency Approves First Respiratory Syncytial Virus Vaccine

In May, the FDA approved GlaxoSmithKline Biologicals’ Arexy, the first respiratory syncytial virus (RSV) vaccine approved for use in the U.S. in adults ages 60 and older. The virus is a common cause of lower respiratory tract disease, which can be serious for older adults as an infection can lead to life-threatening pneumonia and bronchiolitis. Approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults ages 65 and older in the U.S. are caused by RSV every year, according to the Centers for Disease Control and Prevention. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a release.

Hope for Relief of Symptoms Associated with Dementia

Agitation is one of the most common side effects of dementia caused by Alzheimer’s disease. It can lead to pacing, restlessness, and even verbal and physical aggression, and the FDA says it is one of the challenging aspects of caring for patients. The agency recently approved the first-ever drug that treats agitation caused by dementia from Alzheimer’s disease, which was developed in a partnership between Otsuka Pharmaceutical Company and Lundbeck. The treatment, Rexulti (brexpiprazole), is an oral tablet administered once daily. In studies, patients who received 2 mg or 3 mg of Rexulti experienced a drop in the frequency of agitative behaviors.

Gone in a Flash

Every woman is going to experience menopause in her lifetime, and one of the most common (and unpleasant) side effects of the hormonal changes during this transition are hot flashes. More than 80 percent of menopausal women experience sweating, flushing and chills that last for several minutes, and hot flashes can interfere with sleep and quality of life. This May, Astellas received approval for its novel drug, Veozah (fezolinetant), the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. The drug is not a hormonal therapy—it binds to and blocks the NK3 receptor, which plays a role in how the brain regulates body temperature.

New Treatment for Crohn’s Disease

AbbVie’s immunology drug, Rinvoq, was cleared for approval to treat Crohn’s disease. It’s the seventh FDA approval for Rinvoq in less than four years—previously it’s been approved to treat conditions such ulcerative colitis and rheumatoid and psoriatic arthritis.

Better Screening for Preeclampsia in Expectant Mothers

Preeclampsia is a severe pregnancy complication that is the leading cause of maternal and fetal mortality and morbidity worldwide. Pregnant women who are hospitalized for hypertensive disorders (linked to high blood pressure) are at risk of developing preeclampsia, and novel biomarkers from Thermo Fisher Scientific that recently received FDA clearance can help clinicians detect the development of the condition and assess patients. The B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR immunoassays are the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, and the company says in a release they are meant to be used with laboratory tests and other clinical assessments.

Agency Clears IND Application for Novel Treatment of Advanced Solid Tumors

San Diego-based Adcentrx announced in July that the FDA cleared its Investigational New Drug (IND) application for ADRX-0706, an antibody-drug conjugate therapy for certain advanced solid cancer tumors. The antibody targets Nectin-4, a protein that appears in the cells of several types of cancers. The first Phase 1a and 1b clinical trial is set to begin, with the first patient enrolled later this year.

First-Ever Solution for Common Eye Inflammation

You might feel itchy when reading this, but everyone has demodex, or dust mites, that live in our homes and on our skin and hair follicles and it goes unnoticed. For some people, these microscopic organisms can cause allergies or blepharitis: a common chronic eye condition that leads to dry eyes, redness, swelling, and styes. Tarsus Pharmaceuticals made a major breakthrough when Xdemvy, the first-ever treatment specifically for blepharitis caused by demodex, was approved in July.