3 days, 5 approvals: Celgene, AbbVie, Roche meds push FDA tally to 23 for the year

20 August 2019

Eric Sagonowsky / FirecePharma

Lawmakers may have left the nation's capital for summer vacation, but regulators at the FDA are staying busy. The agency churned out five approvals just last week from companies large and small—and five more decisions are due by month's end.

Three of last week's green lights opened the way for launches worth half a billion or more in annual sales. But the week started with a couple of OKs smaller on the sales side, if still significant for the organizations that developed them.

Pretomanid, a tuberculosis med developed by the nonprofit TB Alliance, kicked things off Wednesday with an FDA nod in drug-resistant forms of the disease. On the same day, Philly-area pharma company Harmony Biosciences picked up its first FDA nod ever, passing agency gatekeepers with narcolepsy med W

GlobalData pharma analyst Sarah Elsayed said she expects Wakix to pick up a “small share” of the $1.5 billion narcolepsy market. The drug is a “welcome addition” for doctors and patients, she said, but key opinion leaders told the firm they “believe that Wakix is not as effective" as Jazz Pharma's competing Xyrem, the analyst said.

After those Wednesday approvals, the agency stayed busy Thursday and Friday. Regulators signed off on Roche’s targeted cancer drug Rozlytrek, Celgene’s myelofibrosis med Inrebic and AbbVie’s rheumatoid arthritis treatment Rinvoq in quick succession.

Each med carries significant sales expectations, with Rinvoq leading the group. Evaluate analysts have estimated the drug will generate $2.2 billion by 2024, making Rinvoq a critical launch for AbbVie as it cedes Humira sales to biosimilars in Europe and approaches its U.S. patent cliff in 2023.

Celgene's Inrebic nod should provide a boost for Bristol-Myers Squibb after those companies close their $74 billion megamerger; BMS execs have said the drug is among a group of potential blockbusters at Celgene. Roche's Rozlytrek will challenge Bayer's Vitrakvi in patients 12 and older with tough-to-treat NTRK fusion-positive tumors, but the Swiss pharma giant priced its med at about a 50% discount to Bayer's offering.

While last week proved busy for the agency, they won’t be able to relax right away on the heels of that burst of approvals. The rest of the month features five decision deadlines, according to Vantage, including two today. 

The agency is set to decide on Sarepta Therapeutics’ Duchenne muscular dystrophy treatment golodirsen today as well as Nabriva’s antibiotic lefamulin, Vantage reports. Later this month, the FDA has decision deadlines for Kyowa Kirin’s Parkinson’s disease med Nouriast, Intellipharmaceutics’ previously rejected painkiller Rexista and Nektar Therapeutics’ pain med NKTR-181.

Last week's approvals brought the agency’s total for the year to 23, compared with 30 this time last year. In 2018, agency approvals reached 59 for the year, topping a prior record of 53 set in 1996.  

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