Regeneron | November 24, 2020
Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business.
Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago.
In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others.
Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday.
Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution.
The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab.
Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.
Yiling Pharmaceutical Co | September 19, 2020
Yiling Pharmaceutical Co., Ltd. announced on Friday that it had received the approvals of the Abbreviated New Drug Applications (ANDA) about Lisinopril Tablets and Acyclovir Capsules, from United States Food and Drug Administration (hereinafter referred to as the "FDA"), which were submitted by Yiling Wanzhou International Pharmaceutical Co., Ltd., one of the wholly-owned subsidiaries of Yiling Pharmaceutical Co., Ltd., meaning that these products are approved to be produced and sold in the U.S. market. The announcement showed that Lisinopril Tablets are mainly used for the treatment of essential hypertension (EH) and renal vascular hypertension (RVH) and were originally researched and developed by Astrazeneca and approved for launch in the United States in 1988. Currently its licensed producer is Alvogen Malta Operations Ltd., and the major manufacturers of its generic drugs are Casi, Ascent, and etc. in the United States. In addition to the originally researched and developed drugs, there are 11 producers for the generic drugs in China, among which, only one has passed the consistency evaluation. According to the IMS database, the saleroom of Lisinopril Tablets was about USD 131.39 million in the U.S. market in 2019.
Fiercepharma | June 16, 2020
Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplinza following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch. Doctors could prescribe Roche’s Rituxan or its biosimilars off label before trying Uplinza, Evaluate Vantage reports, or payers could require them to try the cheaper options first. Uplinza is a B cell depleter like Rituxan, so if those older options don’t work, docs might go another route and try Alexion’s Soliris rather than move on to Uplinza, Vantage said.