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Secukinumab gets EC approval for treating hidradenitis suppurativa
Cosentyx® (secukinumab) became the only new biologic approved in the last decade for this condition. It provided rapid symptom relief by week 4, with increasing response rates for up to a year. The safety profile of the drug was already established across other indications. The drug is also used fot treating plaque psoriasis, spondylitis, spondyloarthritis, and arthritis.
Not taking COVID-19 vaccines tied to avoidable hospitalizations
COVID-19 patients who were eligible for vaccination but did not take them had a 10 times higher hospitalization risk than those who received two doses. They also had 21 times higher risk than those who took a booster or a third dose. The study estimated that costs of $101.46 million and $110.24 million could be avoided with full and booster vaccination, respectively.
FDA warns against compounding semaglutide
The agency received reports of adverse events after some patients used compounded semaglutide. Thus, FDA warned against using compounded drugs when an approved drug is available. Patients and physicians are urged to understand that such products may contain salt forms and FDA does not review the safety and effectiveness of compounded versions of drugs.
New treatment for REM sleep behaviour disorder
This disorder is caused due to neurodegeneration from the accumulation of tau protein in the brain. A recent study found that dual orexin receptor antagonists can benefit patients with this condition. These drugs reduced the time to fall asleep and improved the duration and quality of sleep in mouse models, raising hopes for testing these FDA-approved drugs in humans.
Paxlovid gets full FDA approval for treating severe COVID-19
PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) became the first oral treatment for COVID-19 that got FDA approval. It demonstrated an 86% reduction in the risk of hospitalization or death in the phase 2/3 EPIC-HR trial in those who took it within 5 days after symptoms started. The safety of Paxlovid was consistent in patients across the trial and in those who used it.
FDA approves another SGTLT2 inhibitor for treating heart failure
INPEFA™ (sotagliflozin) is a once-daily oral pill meant for lowering the risk of hospitalization, emergency hospital visits, or death from heart failure in patients with heart failure, type 2 diabetes mellitus, kidney disease, and other heart-related risk factors. It is also indicated in full-range LVEF with preserved or reduced ejection fraction, with or without diabetes.
Bariatric surgery lowers the use of antidiabetic and lipid-lowering drugs
A study on more than 26,000 patients who had bariatric surgeries revealed that the usage of cardiovascular, lipid-lowering, and antidiabetic drugs was lower in the long-term in patients who underwent bariatric surgery compared to that in matched controls who did not undergo this surgery. However, the reduction was transient for cardiovascular medications.
Another biosimilar of adalimumab gets FDA approval
Yuflyma® (adalimumab-aaty) is a 100 mg/mL citrate-free biosimilar formulation of Humira's (adalimumab). It can become a critical high-concentration treatment option involving auto-injector administration and pre-filled syringes for patients with inflammatory health conditions like arthritis, inflammatory bowel disease, hidradenitis suppurativa and plaque psoriasis.
India: Tests are mandatory for cough syrups before export
India will now allow exports only after the India-made cough syrup samples pass the tests, as per the regulations from the trade ministry. This decision comes after cough syrups from India caused the deaths of several children in Uzbekistan and Gambia. India is also considering changes in pharmaceutical industry policy to test raw materials used to manufacture drugs.
FDA approves buprenorphine injection to tackle opioid abuse
Brixadi (buprenorphine extended-release subcutaneous injection) can be used for treating opioid use disorder. So far, the drug is available in two formulations, a weekly SC injection and a single-dose transmucosal product. This approval expands dosing choices for patients with sustained and long-term recovery. Injection-site pain, erythema, and pruritus are common side effects.