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Takeda Pharmaceutical Co. Ltd.

www.takeda.com

Latest From Takeda Pharmaceutical Co. Ltd.

NDAC Recommendation To Approve GSK's Mouth Spray NRT Comes With Caveats

No more than three votes decided the panel's recommendation on each FDA question, and members in the prevailing majorities explained they made their votes with reservations. Potential use by young consumers and confusion by adult users in following the label instructions were primary concerns for all panel members.

International United States

'Naturalistic' Trial In GSK's Nicotine Mouth Spray NDA Historic For OTC NRTs

What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.

OTC Drugs FDA

GSK Proposal For Novel Delivery NRT Leaves FDA Doubting 'Real World' Efficacy

In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."

OTC Drugs FDA

Kyprolis-Plus-Darzalex Boosts Amgen's Myeloma Pipeline, After MCL-1 Drugs' Clinical Holds

The company's proteasome inhibitor reduced the risk of death in combination with J&J's CD38 inhibitor in a Phase III trial. A day earlier, Amgen reported clinical holds on its Phase I MCL-1 inhibitors due to cardiac safety.

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