COVID-19 Drug Remdesivir Approved for Infants And Young Children

The FDA said on Monday it has expanded approval of Gilead's antiviral drug remdesivir (Veklury) as the first Covid-19 treatment for infants and young children, for children 28 days or more hospitalized with Covid-19, or Carriers of the virus who have the potential to develop severe disease. Previously, remdesivir (Veklury) was approved by the FDA for the treatment of new crowns in October 2020, becoming the first drug to treat COVID-19, but it was only approved for the treatment of patients 12 years and older.

The approval is based on the results of the Phase 2/3 Caravan study in 53 hospitalized pediatric patients, who treated remdesivir to day 10, with 75% of the participants showing improvement in clinical symptoms and 60% being discharged from the hospital.

AstraZeneca announced on Monday that the FDA has accepted a Biologics License Application (BLA) for its investigational CTLA-4 antibody tremelimumab, which is combined with the anti-PD-L1 antibody Imfinzi (durvalumab) and will be reviewed through the priority review channel. for the treatment of patients with unresectable hepatocellular carcinoma. The combination therapy of Imfinzi and Tremelimumab has been granted orphan drug designation by the US FDA for the treatment of hepatocellular carcinoma (HCC) in January 2020.

The FDA will make an approval decision in the fourth quarter of this year.

Recently, the Japanese pharmaceutical company Shionogi announced at the European Congress of Clinical Microbiology and Infectious Diseases that the results of the phase IIb study of the new crown drug S-217622 showed "rapid clearance" of the new coronavirus.

S-217622 was jointly developed by Hokkaido University and Shionogi. The drug principle is similar to that of Pfizer’s new crown drug Paxlovid. Both inhibit the self-replication of the virus by inhibiting the activity of 3CL protease. Shionogi also said that after structural improvement, S-217622 can get rid of the dependence on P450 enzyme inhibitors (such as ritonavir) and achieve single-drug therapy for the new crown.

Pfizer announced a recall of five batches of Accupril after it found excessive levels of nitrosamines, a potential carcinogen, in its blood pressure drug quinapril hydrochloride (Accupril). The recalled drugs were sold in the United States and its overseas territory Puerto Rico between December 2019 and April 2022, but no reports of adverse reactions have been reported so far.

Nitrosamines have been responsible for multiple recalls in recent years, especially for valsartan and metformin.

Recently, the WHO issued a communiqué stating that as of April 21, 2022, at least 169 cases of acute hepatitis of unknown cause had been reported in 12 countries around the world; including the United Kingdom (114), Spain (13), Israel (12), the United States ( 9), Denmark (6), Ireland (<5), Netherlands (4), Italy (4), Norway (2), France (2), Romania (1) and Belgium (1).

Symptoms of many reported cases include diarrhea and vomiting, most cases have no fever, and five common hepatitis viruses A, B, C, D, and E have not been detected in all reported cases. The WHO said that since the vast majority of patients have not been vaccinated against the new crown, it is believed that it is not a side effect of the new crown vaccine.

Japan's Ministry of Health, Labour and Welfare announced on April 25 that the first case of a child who may have this acute hepatitis has also appeared in Japan.

On Monday, Quoin Pharmaceuticals, a specialty pharmaceutical company focused on rare and orphan diseases, announced that it has received FDA approval to begin clinical trials of its Investigational New Drug (IND) application for QRX003, a treatment for Netherton Syndrome NS ) of a new drug.

NS is a rare, very serious genetic disorder for which there is currently no approved treatment. Netherton patients are deficient in a protein called LEKTI, resulting in excessive skin exfoliation and a highly porous and damaged skin barrier. QRX003 is a topical lotion formulated with a patented delivery technology that contains broad-spectrum serine protease inhibitors whose mechanism of action is to restore the function of the LEKTI protein, normalize skin exfoliation, and form a stronger skin barrier.

Recently, Sanofi China announced that its clinical study LixiLan-O AP of SOLIQUA (iGlarLixi), a fixed-ratio combination of basal insulin and CLP-1RA in the Asia-Pacific region, achieved the primary endpoint of the study.

LixiLan-O AP is an open-label, active-controlled, 24-week clinical trial designed to compare iGlarLixi with basal insulin or GLP-1RA in glycemic control following metformin or without a second oral hypoglycemic agent Efficacy and safety in poor Asia-Pacific patients with type 2 diabetes mellitus (T2DM). The results of the study show that iGlarLixi has an excellent hypoglycemic effect and a higher percentage of reaching the target: at 24 weeks of treatment, the average glycated hemoglobin (HbA1c) of the subjects in the iGlarLixi group reached 6.3%, which was significantly better than the basal insulin group and GLP-1RA group. , 2 hours postprandial blood glucose improvement was significantly better. In addition, iGlarLixi is also more secure.

Recently, Nkarta, a biopharmaceutical company developing natural killer cell cancer therapies, announced that its two chimeric antigen receptor (CAR) natural killer (NK) cell candidate therapies, NKX101 and NKX019, are in two early-stage clinical trials for the treatment of blood cancers. positive results were obtained.

In a Phase 1 clinical trial, Nkarta is using NKX101 in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Trial results were positive, with approximately 60% of patients receiving higher doses of NKX101 achieving complete remission after hematologic recovery.

In another clinical trial, Nkarta used NKX019 to treat relapsed or refractory B-cell malignancies. Of the six patients who received the highest dose, three achieved complete responses, one with aggressive diffuse large B-cell lymphoma and the other with mantle cell lymphoma.

Recently, Biogen announced the withdrawal of the marketing authorization application submitted in Europe. At a previous expert meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said that the clinical efficacy data provided by Biogen for Aduhelm (aducanumab) were insufficient to support its potential approval. In December, the CHMP voted unequivocally against regulatory authorization for the controversial Alzheimer's drug.