Janssen, Brickell and ViiV knock on FDA door

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Two companies said they have submitted regulatory submissions to the U.S. Food and Drug Administration (FDA), and a third reported successful clinical trial data that will form the basis for submission in the coming months. Here is a preview.

Janssen’s Stelara for Juvenile Psoriatic Arthritis

Janssen Pharmaceutical Companies, a Johnson & Johnson Company, submitted a Supplemental Biologic License Application (sBLA) from the United States Food and Drug Administration (FDA) for Stelara (ustekinumab) for children aged five years and older with juvenile psoriatic arthritis (jPsA).

The sBLA is based on extrapolating data from nine studies that included both adult trials in active RP and adult and pediatric trials in moderate to severe plaque psoriasis. This totals 3,997 patients combined. The extrapolation approach is due to the limited availability of pediatric patients for inclusion in clinical trials.

“With this latest submission, we are excited to work with the US FDA to assess this potential treatment option that could help meet the needs of children living with psoriatic arthritis,” said Alyssa Johnsen, vice president, responsible from the field of diseases in rheumatology, Janssen Research and Development.

Brickell’s drug for excessive underarm sweating

Brickell Biotech, although not exactly imminent, plans to submit a New Drug Application (NDA) to the FDA for its sofpironium bromide gel, 15%, sometime in mid-2022. The company announcement the first positive results from the pivotal phase III trials in Cardigan I and II, which evaluated the drug as a once-daily topical formulation in patients with primary axillary hyperhidrosis, which is excessive underarm sweating. They included 350 and 351 participants, aged nine and over, respectively. The trials met all primary and secondary efficacy criteria, showing statistically significant differences between drug and vehicle.

Robert Brown, Chairman and CEO of Brickell, said: “The results of the Cardigan I and Cardigan II studies, along with any clinical studies already completed, will form the basis of a US NDA for sofpironium bromide gel, 15 %, which we plan to submit to the FDA in mid-2022. We greatly appreciate the collaborative and diligent efforts of our patients, study researchers, partners and employees who participated in or contributed to these studies. It was a huge team effort, and we are grateful to everyone who contributed to the success of our Phase III program. “

The new formulation of 3 drugs from ViiV Healthcare for HIV

ViiV Health, an HIV-focused company majority owned by GlaxoSmithKline, with Pfizer and Shionogi Limited as shareholders, has submitted a request to the FDA for a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir and lamivudine, and also to extend the current approval of Triumeq (abacavir / dolutegravir / lamivudine) to decrease the minimum weight or a child can be given the medicine. The drop is from 40 kg and more to 14 kg and more. If approved, it will open up treatment options for young HIV-positive patients.

“UNAIDS reported that by 2020, 74% of adults living with HIV had access to treatment, compared to only 54% of children,” said Deborah Waterhouse, CEO of ViiV. “This is a stark reminder of the gap between treatment options for adults and children and this submission represents another important step in ensuring that we close this gap. By expanding the treatment options available for children living with HIV, we are taking one step closer to ending pediatric HIV and AIDS.


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