US Drug Regulator Approves Valneva's Single-Shot Chikungunya Vaccine Published 32 minutes ago
The US Food and Drug Administration (FDA) has approved Valneva's single-shot vaccine for individuals 18 years of age and older who are at increased risk of exposure to the chikungunya virus. Valneva's vaccine, with the brand name Ixchiq, is the first preventive shot to be approved in the country for the mosquito-borne disease.
“Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus,” the FDA said in a statement on Thursday.
Chikungunya virus spreads to people through the bite of an infected mosquito. The virus is primarily transmitted to people through the bite of an infected mosquito. The most common symptoms of infection are fever and joint pain. Other symptoms may include headache, muscle pain, joint swelling or a rash. According to FDA, Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years.
The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.
This US approval for the vaccine is based on late-stage trials, which showed the vaccine was able to induce antibody levels that could neutralize the chikungunya virus in 98.9 percent of participants for 28 days post-vaccination. The US health regulator, however, asked the company to conduct a post-marketing study to assess the risk of severe chikungunya-like adverse reactions following administration of Ixchiq.
(With agency inputs)
Lupin's Mandideep facility receives EIR from USFDA
Drug maker, Lupin, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Mandideep Unit-2 facility in Madhya Pradesh.
The US drug regulator issues an EIR to a company when an inspection is satisfactorily closed. Lupin received EIR after the last inspection of its Mandideep-based facility was conducted from August 7 to August 11, 2023. Shares of the drug firm ended 1.04 percent down at ₹1,128.40 apiece on the BSE.
Also Read: Lupin Q2 Results: Board to meet on November 8 to discuss unaudited results
This month, the pharma major received approval from the US FDA to market its generic Fluconazole tablets and another generic medicine used to treat daytime sleeplessness. Fluconazole tablets are used in the treatment of fungal infections. The approval was granted by the USFDA for the abbreviated new drug application of Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg, Lupin said in a regulatory filing.
Also Read: Lupin mulls internal restructuring options, looks to separate its API business: Report
These medicines are a generic equivalents of Diflucan tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer Inc, it added. The mentioned generic medicine will be produced by Lupin at its Pithampur facility in India, the company said. The Fluconazole Tablets had an estimated annual sales of $43 million in the US, Lupin said citing IQVIA MAT July 2023 data.
Also Read: Q2 result preview: Strong US performance to lift the show for pharma companies
In the beginning of the month, the company received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (0.5 g/mL), the Mumbai-based drug maker said in a statement. The product is equivalent to the generic equivalent of Jazz Pharmaceuticals' Xywav Oral Solution, said Lupin in its stock exchange filing. The medication will be produced at Lupin's Somerset facility in the US.
As per the estimates, the net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution stood at $ 958.4 million 2022 and $ 604.3 million in the first half of 2023.
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Source: Live Mint
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