Week's news analysis

What sales for 2020 FDA approved medicines?

by the Editor - 25 February 2021

With 53 drugs approved by the FDA, 2020 was very dynamic in terms of new approvals in spite of the sanitary crisis and the economic lockdown. But in the end, which products have taken the lead and reached the most sales?

Among all approvals, Tepezza definitely remained as the most profitable. Horizon Therapeutics medicine indicated in thyroid eye disease (TED) was approved in January by the FDA. At that time, the drugmaker estimated a gradual commercial uptake and modest sales of $40 million by the end of this year. Tepezza ended the year with net sales exceeding $800 million and peak sales at more than $3 billion annually thereafter. Horizon picked up Tepezza while it was still in mid-phase research through its 2017 acquisition of River Vision.

In the fields of cancer, markets are having great expectations on Trodelvy, Gilead's product gained through its $21 billion acquisition of Immunomedics Inc. in September. The company's breast-cancer drug received approval from the FDA in April, to treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Trodelvy generated $64 million in sales in the fourth quarter of 2020 and $137 million over 12 months. According to analysts, Trodelvy could snag $4.7 billion in peak sales in breast cancer alone and $1 billion in third-line breast cancer and bladder cancer.

Meanwhile, Sarclisa's approval in March, marked a "return to oncology" for Sanofi. The medicine was cleared to treat adults with multiple myeloma who have tried at least two other treatments. The approval was based on a phase 3 study adding Sarclisa to the standard of care regimen of Bristol Myers Squibb's Pomalyst and the steroid dexamethasone (pom-dex). Sanofi hopes to bring Sarclisa into earlier lines of treatment. The total third-line market opportunity in the U.S. and major European markets is forecast at $3.4 billion and the second-line market at $6 billion. Full-year sales of Sarclisa reached 43 million Euros.

In January, Ayvakit became Blueprint Medicines' first commercial product after obtaining the FDA go-ahead to treat patients with rare gastrointestinal stromal tumor (GIST) bearing a PDGFR? exon 18 mutation. In September, the European Commission also approved the product. Revenues for the year ended December 31, 2020 were $793.7 million, including $21.2 million of net product revenues from sales of Aykavit.

In April, Koselugo, originally developed by Array BioPharma, got a new life in rare disease with AstraZeneca and its partner, Merck. It was approved as a treatment for neurofibromatosis type 1, a rare neurological disorder that affects an estimated 10,000 to 12,000 children in the US. While awaiting a European green light this year, Koselugo reached sales of $38 million in 2020.

Among the others approved medicines, analysts forecast peak sales of $1 billion for Orgovyx, a new oral treatment for advanced prostate cancer. Myovant Sciences aims to make the treatment (approved in December) the new standard of care as the once-daily pill could avoid in-person injections to patients. In May, Retevmo's approval in RET-positive lung and thyroid cancers was the first to come out of the $8 billion buyout deal from Eli Lilly for Loxo Oncology, where the drug originated.Analysts estimate peak sales over $1 billion. Roche's Evrysdi, approved in August, is the third treatment for spinal muscular atrophy to hit the market, after Biogen's Spinraza and Novartis' gene therapy Zolgensma. Peak sales are estimated between $$2.5 billion to $3 billion.

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