Exciting FDA Drug Approvals in Recent Years

Successful clinical trials that demonstrate increased activity and safety of novel medications result in FDA drug approvals every year. Here are a few recent FDA drug approvals that are especially exciting:

1. Alzheimer's Disease - Aduhelm (Aducanumab)

Aducanumab is a medication that has been approved by the U.S. Food and Drug Administration (FDA) to treat Alzheimer's disease. Aduhelm, the brand name, is the first new medication for Alzheimer's disease in almost 20 years! Aducanumab is a monoclonal antibody that fights beta-amyloid, a protein that builds up in Alzheimer's patients' brains. It is intended to stop the course of cognitive impairment in persons with early-stage Alzheimer's disease. The medication is injected intravenously.

Aduhelm's approval was contentious because there is some disagreement among doctors over the medication's efficacy. Some patients in the clinical trials demonstrated gains in cognitive function, whereas others did not. The medication also carries a hefty price tag, raising questions about accessibility. Despite these issues, Aduhelm's approval has been hailed as a major advance in the fight against Alzheimer's disease, which affects millions of people worldwide. Visit our clinical trial search page to find Alzheimer's Disease clinical trials near you.

2. Non-Small Cell Lung Cancer - Lumakras (Sotorasib)

Lumakras is the brand name for the medication Sotorasib, which the U.S. Food and Drug Administration (FDA) approved in May 2021 for the treatment of specific forms of advanced non-small cell lung cancer (NSCLC). Sotorasib is a targeted medication that blocks the KRAS G12C genetic mutation, which accounts for roughly 13% of NSCLC cases. The medication, which is taken orally as tablets, is intended to decrease the growth and metastasis of cancer cells in persons who have this mutation. This was the first FDA approval of a medication that targets KRAS, which has long been known to be a key oncogene responsible for aggressive malignancies.

The approval of Lumakras was hailed as a major advancement in the management of NSCLC, the most prevalent form of lung cancer. Participants in sotorasib clinical studies reported meaningful decreases in tumor size and increased progression-free survival, which are encouraging findings. However, the medication may have unwanted effects such as fatigue, nausea, and diarrhea. Sotorasib is a novel treatment option for those with NSCLC and the KRAS G12C mutation despite these side effects. Visit our clinical trial search page to find Lung Cancer clinical trials near you.

3. Multiple Myeloma - Abecma (idecabtagene vicleucel)

The medicine idecabtagene vicleucel, also known by the brand name Abecma, was given FDA approval in March 2021 to treat specific forms of advanced multiple myeloma.

Chimeric antigen receptor (CAR) T-cell therapy, a subset of cellular immunotherapy, uses idecabtagene vicleucel. The medication works by genetically modifying T-cells from the patient's own immune system to recognize and attack a particular protein called B-cell maturation antigen (BCMA), which is found on the surface of multiple myeloma cells. The altered T-cells are then reintroduced into the body of the patient, where they can find and eliminate cancer cells.

The approval of Abecma, a cancer type that affects plasma cells in the bone marrow, was hailed as a significant advancement in the treatment of multiple myeloma. Advanced multiple myeloma patients had few available therapy choices prior to the introduction of idecabtagene vicleucel. It has demonstrated excellent outcomes in clinical trials, where patients saw significant tumor size reductions and prolonged progression-free survival. However, the medication can have serious, and even fatal, side effects, such as neurotoxicity and cytokine release syndrome (CRS). Idecabtagene vicleucel is a novel therapy option for those with advanced multiple myeloma who have not responded to prior therapies, despite these possible adverse effects. Visit our clinical trial search page to find Cancer clinical trials near you.

4. Diabetes - Zegalogue (Dasiglucagon)

Dasiglucagon, also known as Zegalogue, is a medication that has been approved by the U.S. Food and Drug Administration (FDA) to treat severe hypoglycemia in diabetics 6 years of age and older.

Dasiglucagon is a synthetic version of the pancreas-produced hormone glucagon, which helps control blood sugar levels. It is intended to swiftly boost blood sugar levels in persons with severe hypoglycemia, a condition that if left untreated, can result in unconsciousness or seizures. The medication is administered by a pre-filled, single-dose syringe. Zegalogue's approval was viewed as a significant advancement in the management of severe hypoglycemia, a frequent and fatal consequence of diabetes. The sole treatment for extreme hypoglycemia prior to the approval of dasiglucagon was an injectable type of glucagon that needed to be mixed before use, which might be time-consuming and challenging in emergency situations. Dasiglucagon has demonstrated encouraging results in clinical trials. Participants' blood sugar levels significantly increased within 10 minutes of administration. The medication could have possible negative effects, which include nausea and vomiting. Visit our clinical trial search page to find Diabetes clinical trials near you.

These new medications open the door for additional investigation and the creation of novel therapies by representing new ways to treat disease. It is crucial to remember that medicine availability and approvals may differ by country, and that the FDA may approve newer, better medications that outperform those on the above list. The best approach to get the most up-to-date information on drugs and treatments is to speak with a healthcare practitioner.

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