Drugmakers large and small score FDA nods in busy week of approvals

29 August 2018

Eric Sagonowsky / FiercePharma

A group of drugmakers large and small scored FDA nods in a busy week for the agency. Aside from a blockbuster nod for Shire, Kala Pharmaceuticals secured a Thursday approval for Inveltys to treat ocular pain and inflammation after surgery, while Italian and French companies, plus a Bausch unit, won their own FDA nods.

Kala expects to hire a specialty sales force and launch Inveltys in early 2019, CEO Mark Iwicki said in a statement. In a note Thursday, Wells Fargo analyst David Maris wrote that he expects the drug to generate $25 million in sales next year and $345 million by 2025. The drug is administered twice per day, compared to competitors that are administered four times a day, Maris pointed out.

Meanwhile, Bausch Health Companies unit Ortho Dermatologics won approval Friday morning for Altreno to treat acne vulgaris in patients 9 and older. The drugmaker expects to launch in the fourth quarter.  

The approvals came as Shire bagged its important FDA nod for Takhzyro, formerly known as lanadelumab, to treat hereditary angioedema in patients 12 and older. Analysts expect the drug to pull in $1.8 billion sales at peak. 

Earlier in the week, Italian drugmaker Dompé secured a nod for Oxervate to treat neurotrophic keratitis, a rare eye disease. The approval marks the first for Dompé in the U.S. and the first nod for an NK drug. 

And finally on Monday, the FDA signed off on BioCodex’s Diacomit to treat seizures associated with Dravet syndrome in patients two years and older who are taking clobazam. The French drugmaker expects to launch in early 2019. 

This week’s nods pushed the FDA’s approvals for 2018 past 30, as detailed in the agency’s running list. Last year, the FDA approved 46 novel drugs. 


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