As we approach the end of the summer, we wanted to look back on the new approvals that the Food and Drug administration (FDA) have made. From medications for cancer to mental disorders to rare diseases to yeast infections, the FDA has been working hard to make a difference for people with these issues. Without them, life would be much more difficult for patients and doctors alike. Here are some new approvals that have been made this summer:
- Rybrevant– May 21
The FDA has granted the accelerated approval of RYBREVANTTM, the first fully-human, bispecific antibody for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
- Pylarify– May 26
The PYLARIFY® injection is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
- Lumakras– May 28
The first once-daily oral treatment for people living with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery, and whose tumor is KRAS G12C positive, and who have received at least one prior treatment.
- Truseltiq– May 28
TRUSELTIQ is a prescription medicine used to treat adults with bile duct cancer that has spread or cannot be removed by surgery, who have already received a previous treatment, and whose tumor has a certain type of abnormal “FGFR2” gene. It is approved based on tumor response and duration of response.
- Lybalvi– May 28
LYBALVI is a once-daily, oral atypical antipsychotic that has been approved for the treatment of Schizophrenia and Bipolar I Disorder in adults. It is a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.
- Brexafemme– June 1
BREXAFEMME® has been approved for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. It represents the first approved drug in a novel antifungal class in more than 20 years.
- Aduhelm– June 7
The FDA has granted accelerated approval for ADUHELM™ (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. Clinical trials have proven ADUHELM to reduce amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
- Rylaze– June 30
Rylaze™ has been approved for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. It is the only recombinant erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment.
- Kerendia– July 9
Kerendia has been approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks and hospitalization for heart failure in patients with chronic kidney disease associated with Type 2 diabetes. It will become the first nonsteroidal mineralocorticoid receptor antagonist, or MRA, approved for diabetic kidney and heart disease.
- Fexinidazole– July 16
Fexinidazole is the first all-oral treatment for both stages of T.b. gambiense sleeping sickness, the most common form of the disease. Fexinidazole is an oral pill taken for 10 days, offering significant advantages over the previous standard of care, NECT, because it eliminates the need for systematic hospitalization and leads to a reduction in the number of lumbar punctures.
- Rezurock– July 16
REZUROCK is a prescription medicine used to treat adults and children 12 years of age and older with chronic graft-versus-host disease (chronic GVHD) after you have received at least 2 prior treatments (systemic therapy) and they did not work. REZUROCK tablets are for oral administration. Each tablet contains 200 mg of the free base equivalent to 242.5 mg of belumosudil mesylate.
- Bylvay– July 20
Bylvay (odevixibat) is an ileal bile acid transporter (IBAT) inhibitor used to treat itching (pruritus) in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). BYLVAY is available for oral administration as oral pellets or capsules.
- Saphnelo– July 30
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. It is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with systemic lupus erythematosus.
- Nexviazyme– August 6
Nexviazyme has been approved for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder that impairs a person’s ability to move and breathe. It is an enzyme replacement therapy (ERT) designed to specifically target the mannose-6-phosphate (M6P) receptor, the key pathway for cellular uptake of enzyme replacement therapy in Pompe disease.
- Welireg– August 13
WELIREG is the first oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. As an inhibitor of HIF-2α, WELIREG reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth.
Thank you to all that are involved in these major accomplishments. For more FDA approvals, check out the FDA website.