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. 


Previous publication Next publication

Media Center

  • 19 October 2018

    FDA Publishes Guidance on the Rare Disease Treatments

    FDA published draft guidance on October 15, 2018 to assist sponsors developing treatments for rare diseases plan for pre-investigational new drug application (pre-IND) meetings with FDA. In the guidance, the agency describes topics that should be considered in early drug development and pre-IND meetings.

  • 18 October 2018

    Russia emerges as frontrunner in global fight against tuberculosis

    Russia has turned out to be the world’s most successful tuberculosis fighter, Russian Health Minister Veronika Skvortsova stated  during the interview with the Rossiya-24 channel. "We are the global leader according to the pace in solving this issue," she noted, adding, "all countries acknowledge Russia’s foremost role here."

  • 17 October 2018

    Scientists developed new tool for open exchange of biomaterials

    A new easy-to-use legal tool that enables open exchange of biological materials was launched. The OpenMTA is a Material Transfer Agreement (MTA) designed to support openness, sharing and innovation in global biotechnology. Material Transfer Agreements (MTAs) provide the legal frameworks within which research organisations define terms and conditions for sharing their materials – everything from DNA molecules to plant seeds to patient samples.

  • 16 October 2018

    The First FDA-approved Digital Pill — What It Means for Pharma

    Last year, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill that is integrated with an ingestible sensor that captures information about whether the patient has complied with her medication regimen. A patient ingests the pill and it sends the data to a patch worn on her torso, which adds various physiologic measures. From there the information is wirelessly sent to a mobile phone app, allowing both the patient and her physician to track how the patient is using and responding to her medication.

Read more