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After a slow 2016, FDA's racking up drug approvals lickety-split

June 26, 2017
Life sciences

Halfway into 2017, the FDA has beaten last year’s drug-approvals tally with a crop featuring controversy, sales firepower and one very high price.

Friday’s approval for the Portola anticoagulant Bevyxxa pushed the count for this year to 23, surpassing 2016’s new drug haul of 22, according to agency stats. The latest green light comes after the U.S. drug regulator signed off on more drugs in the first three months of the year—12—than during any other first quarter in recent years.

So far, this year’s round of new drugs has triggered one pricing controversy and delivered two meds with some serious sales firepower. And among those 23, one has joined the ranks of the world’s most expensive treatments.

For controversy, industry watchers won’t forget Marathon’s Emflaza, a decades-old steroid that’s long been available for about $1,000 per year in other countries; in February, the drugmaker won an FDA orphan approval in Duchenne muscular dystrophy and placed an $89,000 price tag on its med. Facing backlash, the company sold Emflaza to PTC Therapeutics and resigned from industry trade group PhRMA.

Two meds with particularly strong sales potential in the group are Ocrevus, the multiple sclerosis med from Roche, and Dupixent, an atopic dermatitis therapy from partners Sanofi and Regeneron. Analysts expect both to pass $4 billion in sales by 2022, representing this year’s biggest launches, according to EP Vantage.

The 2017 batch also features one of the most expensive therapies in the world, BioMarin’s Brineura, which treats the ultrarare CLN2 disease. After winning approval back in April, the drugmaker priced its med at $702,000, but is planning to offer significant discounts.

Other recent approvals include Melinta Therapeutics’ bacterial skin infection med Baxdela and rheumatoid arthritis entrant Kevzara from Sanofi and Regeneron. Looking to steal share in a tough field, the partners priced their blockbuster hopeful at a 30% discount to the two leading TNF-alpha inhibitors.

The FDA’s new drug approval tally for 2016 came in as a major slowdown from boom years of 2014 and 2015, when the agency approved 41 and 45 new meds, respectively.

By Eric Sagonowsky

Source: Fierce Pharma

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