Merck's K drug is approved for new indications in the United States and Europe, Ogalon acquires Alydia

CompilationFan Dongdong, Ke Ke

This week was an extremely busy week for Merck.

"K medicine" hits a wall in the United States

A few days ago, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Merck for the use of Keytruda in the treatment of high-risk early triple-negative breast cancer (TNBC) for supplementary biological license applications (sBLA).

It is not surprising that Keytruda suffered a setback in sBLA this time.

KEYNOTE-522 is a randomized, double-blind trial conducted in patients with high-risk early stage TNBC.

"K medicine" welcomes good news in the European market

Although Keytruda hit a wall in the United States, the drug has good news in Europe for another indication.

The EU approval is mainly based on the test results of the single-arm study KEYNOTE-052.

Spin-off company Organon acquires Alydia Health

In addition, Merck announced that it will merge its multi-billion-dollar women's health investment portfolio into the new company Organon soon after it is ready for its first acquisition.

As one of the "Top 15 Medical Technology Companies" selected by Fierce Pharma website this year, Alydia health will receive a series of payments following the acquisition and spin-off.

Alydia's Jada device is designed to treat postpartum hemorrhage, which refers to excessive bleeding that may occur after childbirth.

The device enters Organon's contraceptive implants and movable contraceptive device combination (including Nexplanon and NuvaRing), and Organon's female products also include a series of biosimilars developed in cooperation with Samsung Bioepis.

According to reports, Organon’s products achieved revenue of 6.

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Original title: Merck’s big event: K drug treatment of TNBC was rejected by FDA, UC indication was approved in Europe, spin-off company Organon acquired Alydia Health