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Lawmakers may have left the nation's capital for the summer holidays, but FDA regulators remain busy. The agency got five approvals from companies of all sizes last week. Five more decisions are due by the end of the month.
Three of last week's green lights have paved the way for annual sales launches of half a billion or so. But the week has begun with some smaller OKs on the sales side, even though they remain important to the organizations that developed them.
Pretomanid, a TB drug developed by the TB Alliance, a nonprofit, launched its activities Wednesday with a FDA eye patch to the drug-resistant forms of the disease. On the same day, the pharmaceutical company Harmony Biosciences, located in the Philly area, received its first FDA sign, passing the agency's guardians with Wakix's narcolepsy.
GlobalData's pharmaceutical analyst, Sarah Elsayed, expects Wakix to take a "small share" of the $ 1.5 billion narcolepsy market. The drug is a "welcome addition" for doctors and patients, she said, but leading opinion leaders told the company "that they were convinced that was not as effective "as the competitor Xyrem of Jazz Pharma, said the analyst.
After Wednesday's approvals, the agency remained busy Thursday and Friday. Regulatory authorities have approved Rozlytrek, Roche's targeted anti-cancer drug, Celgene's Inrebic myelofibrosis medication and Rinvoq's AbbVie rheumatoid arthritis treatment.
Each med carries significant sales expectations, with Rinvoq leading the group. Analysts estimate the drug would generate $ 2.2 billion by 2024, making Rinvoq a vital product for AbbVie, as it sells Humira's sales to biosimilars in Europe and moves closer to its US patent cliff in 2023 .
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Celgene's Inrebic program is expected to boost Bristol-Myers Squibb after the companies close their $ 74 billion megger; BMS executives said the drug was part of a group of potential blockbusters at Celgene. Roche's Rozlytrek will challenge Bayer's Vitrakvi in patients aged 12 and over with hard-to-treat NTRK positive fusion tumors, but the Swiss pharmaceutical giant has estimated that its drug is worth about 50% off Bayer's offer.
Although last week proved to be busy with the agency, she will not be able to relax immediately after this wave of approvals. The rest of the month has five decision deadlines, according to Vantage, including two today.
The agency is about to decide on the treatment of golodirsen muscular dystrophy Sarepta Therapeutics by Duchenne as well as the antibiotic lepamulin Nabriva, reports Vantage. Later this month, the FDA set a decision period for the treatment of Parkinson's disease by Kyowa Kirin, Nouripast of Intellipharmaceutics, which had previously been rejected, the pain medication Rexista and for the treatment of pain NKTR- 181 by Nektar Therapeutics.
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Last week's approvals brought the total agencies for the year to 23, up from 30 at the same time last year. In 2018, the number of approvals approved by the agencies reached 59 for the year, exceeding the previous record of 53 established in 1996.
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