2020 inventory: FDA and EMA approve peak sales forecast for new drugs!

2020 has been an "evented autumn" for the pharmaceutical industry, with a number of pharmaceutical companies around the world developing Covid-19 therapeutic drugs or vaccines at a feverish pace.
, Covid-19 has claimed about 1.94 million lives worldwide.
drug regulators suspended on-site inspections as countries imposed blockades, and approval rates for new drugs were expected to be much lower by mid-2020.
but after studying new drug approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) last July, the FDA had approved 33 new drugs by the end of June.
figure is within the average for the past two years, companies are seeing hope in the impact of the Covid-19 pandemic.
as of December 31, the FDA had granted 58 new drug approvals, the Drug Evaluation and Research Center had approved 53 chemicals, and the Biologics Evaluation and Research Center had approved five biologics.
even higher than the number of new drug approvals (54) in 2019.
, Lilly and Gilead each had four new drug adaptations approved, and ranked first.
, 23 items were approved in the field of cancer, 16 cases of infectious diseases and infections, 8 items of genetic diseases, 8 items of neurology, 3 items of immunology and 2 items of gastroenterology.
source: Pharma Compass EMA has had a busy year, posting 75 positive comments.
novart won eight of the 75 approved new drug adaptations, followed by Pfizer and Sanofi with four each.
by field of treatment, 21 cases of cancer, 19 cases of infectious diseases and infections, 6 cases of genetic diseases, 5 items of immunology, 5 items of lung/respiratory diseases, 4 items of heart/vascular diseases, 4 items of endocrinology and 4 items of neuropathy.
: PharmaCompass' year marked by EUA has made headlines with the emergency use of drugs (EUAs) as the Covid-19 pandemic rages around the world.
2020, the FDA released 10 EUAs, the most representative of which is the Pfizer/BioNTech and Moderna's Covid-19 vaccine.
are also controversial products in the EUAs.
, for example, the FDA released EUA in March for the oral treatment of chloroquine phosphate and hydroxychloroquine sulfate.
in June, the EUA had been withdrawn after the FDA determined that chloroquine and hydroxychloroquine were unlikely to be effective in treating Covid-19.
at the same time, EUAs produced heavy drugs, and in May the FDA approved the emergency use of Gilead's antiviral drug, remdesivir, which quickly climbed to the top of the list of the best-selling drugs of 2020.
last October, the drug became the first FDA-approved treatment for patients who needed hospitalization for Covid-19.
While the prospects for treatment of the drug in Patients with Covid-19 remain uncertain, particularly as the World Health Organization(WHO)-led trial results show that Redsyvir has little impact on Covid-19 patients' 28-day mortality or length of stay in hospital, analysts expect Redsyvir to peak at $3.5 billion in sales.
2020 FDA Approved Drug Sales TOP10 Forecast Source: PharmaCompass 2020 European Medicines Agency (EMA) Approved Drug Sales TOP10 Forecast Source: Pharma Compass Gilead's $21 billion acquisition of Immunomedics In addition to Redsyve's success, the global pharmaceutical industry includes Gilead in 2020.
April, Immunomedics' antibody drug binding (ADC) Trodelvy (sacituzumab-govitecan-hziy) was approved by the FDA for adult patients with metastassic trisomy breast cancer who had previously received at least two treatments.
these tumors account for 15 to 20 per cent of breast cancer patients.
Trodelvy was named the FDA's most promising drug of all time in 2020, following Redsyvir.
company now forecasts Trodelvy sales of $2.151 billion by 2026.
just five months later, in September 2020, Gilead decided to take a major step in its $21 billion acquisition of biotech company Immunomedics.
deal, which was completed in October, strengthens Gilead's cancer portfolio and adds another potential bombshell to it.
Immunomedics is planning to submit a Supplemental Biologics License Application (BLA) to support Trodelvy's full approval in the U.S. in the first quarter of this year.
, Immunomedics is expected to apply for regulatory approval for Trodelvy in Europe in the first half of 2021.
, ongoing research is evaluating the drug's potential to treat non-small cell lung cancer and other types of solid tumors.
, developed by Roche and PTC Therapeutics, was approved as the first oral drug to treat spinal muscular dystrophy (SMA) after the FDA approved the sale of the promising new drug Troveldy.
until four years ago, there was no cure available for this rare genetic disease.
2016, the drug Spinraza (nusinersen), developed by Yan Jian and Ionis, was approved as the world's first drug to treat SMA.
RNA-based drug is injected in the intransitter and needs to be infused three times a year at the doctor's office.
May 2019, Novart gene therapy Zolgensma (onasemnogene abeparvovec) was approved as the world's first gene therapy to treat SMA.
the drug is administered through a single, one-time intravenous infusion.
Evrysdi's approval provides patients and their families with another unique option: to take their medication daily at home.
, which is priced at patient weight, costs a maximum of $340,000 a year, far less than the competing products already available in Yanjian and Novartic.
Vertex's Kaftrio has been approved by EMA for Vertex's cystic fibrosis treatment, Trikafta, a combination of ivacaftor, tezacaftor and elexacaftor, and its excellent clinical data enabled the FDA to approve the drug within three months of Vertex's application for listing and five months before FDA action.
tops FDA-approved sales forecasts for new drugs in 2019, with sales expected to reach $3.935 billion by 2024.
June 2020, the EMA Committee on Human Drug Use (CHMP) adopted a positive opinion recommending that Vertex be granted a marketing license for the combination of drugs and marketed under the Name of The Kaftrio product.
the European market, the drug will further create a peak in sales.
setbacks in the approval of new treatments, 2020 has not been smooth.
fact, there have been many twists and turns during the year - 44 drugs have not been approved by the FDA.
BMS is one of the companies that has suffered setbacks.
BMS has offered shares in CVR to new shareholders as part of its $74bn acquisition of Celgene.
the agreement, CVR would give new base shareholders a one-time, predetermined return of $9 per share, provided that the three pre-base drugs were approved within a pre-defined period of time.
last March, the FDA approved Ozanimod, a 1-phosphate pyrethroid-infested agonist for the treatment of relapsed multiple sclerosis, produced by BMS and Bluebird Bio, well ahead of the December 31, 2020 deadline.
but there is no progress in approving the remaining two drugs.
May, the two companies announced that they had received a rejection letter from the U.S. FDA of their application for a biological agent license (BLA) for untreated, severe, recurring, refractic multiple myeloma patients.
preliminary review, the FDA concluded that the chemical, manufacturing and control (CMC) modules of ide-cel needed to provide further details to complete the review.
to give a decision on approval by March 31, 2021.
, BMS announced that the FDA had extended the validity of another CD19-guided CAR-T treatment, lisocabtagene maraleucel(liso-cel), by three months until November 16, 2020.
liso-cel is used in adult patients with recurring or incurable large B-cell lymphoma who have received at least two previous treatments.
on November 16, the FDA continued to notify liso-cel that the BLA review could not be completed.
is still silent.
, the FDA also refused to approve Novaral's fat-lowering drug, inclisiran.
2019, Novart bought The Medicines Company for $9.7 billion because of Its interest in the latter-owned incisiran.
the drug has been approved for sale by the European Commission.
said the FDA had not raised any concerns about the efficacy or safety of inclisiran.
's refusal was due to unresolved conditions related to inspections of pharmaceutical facilities.
and the FDA did not conduct on-site inspections.
: A year of barriers and race against time, like pharmaceutical companies, drug regulators around the world are working at a frenzied pace to speed up drug approval and EUAs, especially for Covid-19 treatments and vaccines.
In addition to Covid-19, cell and gene therapy was more widely adopted and approved during the year, along with the approval of innovative drugs such as relugolix (the first oral progesterone-releasing hormone antagonist for the treatment of patients with advanced prostate cancer in adults), and berotralstat (the first oral daily Plasma kinetic peptides release enzyme inhibitors to prevent the onset of hereditary angioedema in adults and children 12 years and older), lumasiran (a HAO1-directed small interfering cycleric acid used to treat primary high oxalic acid urine type 1 in children and adults, reducing urinary oxalic acid levels), and osilodrostat (treating Cushing disease in adults).
addition, there have been some interesting "non-Covid" medical breakthroughs during 2020.
breakthrough was the development of a single tablet that combines four drugs to lower blood pressure, cholesterol, and aspirin, which reduces the risk of heart disease.
While the agility shown by pharmaceutical companies and regulators has been impressive, with many countries granting the Covid-19 vaccine to the EUA, the ongoing pandemic has put humans in a difficult position for months.
the new coronavirus crisis will not be the last pandemic, and efforts to improve human health will be "destined" to fail if climate change and animal problems are not addressed.
so from this pandemic, the pharmaceutical industry may have a lot to learn and summarize.
: 1. New Drugs Approvals by FDA and EMA: 2020 Recap 2. AveXis receives EC approval and activates “Day One” access program for Zolgensma, the only gene therapy for spinal muscular atrophy (SMA) 3. Bristol Myers' $9 Celgene CVR is teetering on the brink of disaster as the FDA delays the liso-cel application yet again 4. CVR tied to BMS's Celgene takeover dealt blow as FDA again delays liso-cel review