US FDA grants standard approval of Eisai/Biogen Alzheimer’s drug

Eisai and Biogen’s Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration on Thursday, the first Alzheimer’s treatment to achieve that goal, clearing the way for wider insurance coverage of the drug.
The FDA decision marks a new milestone for a fatal disease that has eluded drugmakers’ efforts for decades. Trial data showed that the treatment slows the progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer’s.
The FDA also placed its strongest “boxed” safety warning on Leqembi’s label, flagging the risk of potentially dangerous brain swelling for Alzheimer’s drugs in the same class.
Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer’s patients.
Leqembi received “accelerated” FDA approval in January based on its amyloid-clearing ability, but the U.S. government’s Medicare health plan for people aged 65 and over had restricted coverage only to patients in a clinical trial.
Standard approval means that Leqembi will now be covered, although the Centers for Medicare and Medicaid Services (CMS) is linking reimbursement to patient participation in a health agency database, known as a registry. Since Alzheimer’s is a disease of aging, most U.S. patients are insured by Medicare.

The official announcement is on!

U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Today, the U.S. FDA approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. 
GSK’s RSVPreF3 (Arexvy), is a recombinant product that contains a glycoprotein antigen based on the RSV A subgroup and is given with a proprietary adjuvant—the same one in GSK‘s Shingrix shingles (herpes zoster) vaccine—designed to boost the immune response.

See the FDA annucement here

First-in-Class Small Molecule Drug Approvals of 2022

First-in-Class Small Molecule Drug Approvals of 2022
Great collection by Drug Hunter.

Of the 36 novel small-molecule and large-molecule drugs approved by the FDA in 2022, 18 were first-in-class approvals, including 9 small molecules (excluding atoms).

Some of the notable small molecule first-in-class approvals of 2022 include:
Sunlenca (lenacapavir): the first approved drug targeting HIV-1 capsid, indicated for multi-drug resistant HIV with an impressive bi-annual dosing regimen (Gilead Sciences)

Sotyktu (deucravacitinib): the first approved de novo deuterated drug – an oral, allosteric tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis (Bristol Myers Squibb)

Ztalmy (ganaxolone): the first neurosteroid to be studied for epilepsy, approved for treating seizures in cyclin-dependent kinase-like 5 deficiency disorder, an oral GABA-A receptor modulator (Marinus Pharma) – a cyclodextrin-enabled formulation

Pyrukynd (mitapivat): the first approved therapeutic for pyruvate kinase (PK) deficiency – an oral pyruvate kinase activator that improves hemolytic anemia (Agios Pharmaceuticals)

Voquezna (vonoprazan): the first potassium-competitive acid blocker that acts via reversible potassium-competitive ion binding, approved for Helicobacter pylori infection (Phathom Pharmaceuticals)

See the full article here.