Mid-2020 review: FDA-EMA-33-41 new drugs approved, 20 still rejected; BMS, AbbVie...

Read: FDA and EMA 2020 New Drug Approval Profile!---- If you think Covid-19 has delayed approval of new drugs from the U.SFood and Drug Administration (FDA), you're wrongEven as the outbreak spreads, the FDA seems more active than everBy the end of June 2020, the FDA had approved 33 new drugs, and according to this trend, approvals for new drugs in 2020 were roughly the same as in the previous two years (62 new drugs approved in 2018 and 54 in 2019)Meanwhile, the European Medicines Agency (EMA), which approved 41 drugs in the first half of the year, is also busy, including 27 for new treatmentsOf the 33 new drugs approved by the FDA, the Center for Drug Review and Research (CDER) reviewed 25 new molecular entities and new therapeutic biologics, almost half (12) of which were oncology drugsThe field of oncology (10) drugs approved by the EMA also dominatesAfter analyzing the fda and EMA's first-half approval of new drugs, Compass Pharma recently predicted sales of TOP10 drugs, as follows: Conditionally approved Remdesivir is the biggest winner of the year, Gilead Remdesivir , and is undoubtedly one of the most talked about drugs this yearAlthough some of the drug's research is still under clinical evaluation, the FDA, the European EMA and the U.SMinistry of Health and Labour (MHLW) all provide market access for the drugOn May 1 this year, the FDA, based on all the scientific evidence available, was the first to issue an Emergency Use Authorization (EUA), arguing that Remdesivir may be effective in treating Covid-19 and that the known and potential benefits of treating Covid-19 outweigh its risksOn June 25th the EMA Human Drug Commission (CHMP) issued a positive opinion recommending that the drug ,The European trade name Veklury) be licensed for "conditional" saleRemdesivir was in short supply as it went on sale, buying more than half a million doses in the US, which was 100 per cent of Gilead's production in July and 90 per cent in August-September, leaving little inventory in the UK and EuropeIn 127 low- or middle-income countries, Gilead allowed generic drugmakers to supply the drug, further expanding its supplyWith the exception of Remdesivir, most drugs are approved in the order of the First U.Sand then eu after the European Union, such as trikafta,a three-drug combination, which was approved by the FDA three months after the listing application was submitted for outstanding clinical data (October 2019) In June, the EMA adopted chMP's positive advice and granted marketing rights to the combination drug Kaftrio (European product name) The likes of Novartis/Avexis' Zolgensma, Novartis Piqray, Pfizer Staquis and Daurismo are all approved by the FDA in 2019 The approval of several "first" drugs this year also saw the first non-statins approved for sale in the United States in nearly 20 years The drug, called Nexletol (bempedoic acid), is produced by Esperion Therapeutics and is designed to help millions of patients who cannot tolerate or obtain satisfaction from widely used statins such as liptorand and can be determined to lower cholesterol The new drug will be used as an add-on to statins, reducing the amount of harmful cholesterol or low-density lipoprotein (LDL) in the liver and targeting patients at high cardiovascular risk In addition, bempedoic acid was approved in conjunction with another cholesterol-lowering drug, ezetimibe Trodelvy, the first FDA-approved antibody drug conjugated (ADC) for recurrent or refractory mTNBC, and the first ADC drug to fight glycoprotein Trop-2, offers hope to TNBC patients who are ineffective with hormone therapy and HER2 targeted therapies such as Trastuzumab The drug combines antibodies with TROP-2 antigens expressed on most breast cancer cells, delivers the chemotherapy drug Iliticon directly to tumor cell microenvironments, and also delivers the drug to tumor cells that do not express Trop-2, thereby reducing the toxic effects of previous systemic administration  Nearly 20 drugs have not been approved in the outbreak setback, some drugs approval is not smooth About 20 new drugs were rejected by the FDA in the first half of this year, including BMS and Bluebird Bio's CAR-Tide-Vicleuel (Cel) for recurrent and refractory multiple myeloma, which the FDA says requires further details to complete the review, but not additional clinical data In addition, Intarcia Therapeutics' long-term implantation drug ITCA-650 was rejected again two years after receiving rejection, and it is understood that the implant was designed as a small osmotic pump that can slide under the skin and provided a continuous dose of 6 months of GLP-1 agonisant exena tide (Essena tide) The FDA also did not approve Intercept Pharmaceuticals' non-alcoholic fatty hepatitis (NASH) treatment drug, obeticholic acid, because it did not believe the benefits outweighed the potential risks After acquiring Aer Gen for $63 billion, AbbVie hopes to be one of the first drugs approved for the experimental DARPin ® therapy for new blood vessels (wet) age-related macular degeneration (nAMD) However, the FDA study noted that an increase in inflammation in the patient's eye was observed after administration, resulting in a negative benefit-risk ratio, and the drug was rejected To sum up, while all eyes are on the Covid-19 pandemic, regulators are busy getting new drugs on the market By mid-year, we realized that the FDA and EMA looked on track to set approval records this year, as the number of drugs approved by June was almost double the number approved in the same period last year While the number of approvals has not decreased, the Covid-19 pandemic has hampered the smooth launch of the drug, resulting in sales losses THE BMS'S MULTIPLE SCLEROSIS TREATMENT, ZEPOSIA, IS CURRENTLY APPROVED IN THE UNITED STATES AND EUROPE AND IS ONE OF THE MOST ANTICIPATED DRUG APPROVALS THIS YEAR The drug is also a core product of BMS's $74 billion acquisition of Celgene and returns for investors in both companies However, the listing of Zeposia will be delayed due to a global outbreak It remains to be seen how companies will adjust their sales and marketing strategies at a time when liquidity is likely to be limited globally and business transactions are significantly reduced  Reference New Drug Approves by FDA and EMA (Mid-2020 Recap) US secures world stock of key Covid-19 drug remdesivirBristols Squibb and bluebird bio-provide rife on Idecabta Viclesece (ide-cel, bb2121) for the treatment of the