Media Coverage

KindredBio's Zimeta awaits pre-approval manufacturer inspection

Apr 25, 2018 - Animal Pharm
By Joseph Harvey
Animal Pharm
April 25, 2018

Kindred Biosciences must wait for the outcome of a pre-approval contract manufacturer inspection before its Zimeta IV product candidate is authorized for the US market.

The San Francisco-based company recently completed the chemistry, manufacturing and controls technical section for Zimeta IV (dipyrone injection), which is for the control of fever in horses. The US FDA had no additional requests for KindredBio regarding the submission.

However, the FDA said the drug's unnamed contract manufacturer must complete an inspection scheduled for July 2018. The inspection will look for the resolution of issues identified during a previous examination of the manufacturing facility, which was conducted this month.

KindredBio said it believes the issues at the contract manufacturer are "minor and addressable".

This further inspection will slightly delay the approval of Zimeta, which the company had previously pencilled in for the first half of 2018. The firm is also developing Zimeta as a dipyrone oral gel for the control of pyrexia in horses. The company told Animal Pharm it is not using the same manufacturer for Zimeta Oral as it is for Zimeta IV.

Elsewhere in KindredBio's pipeline, the company is developing Mirataz (mirtazapine transdermal ointment) for the management of weight loss in cats. The firm continues to anticipate US approval of Mirataz in May. This would be KindredBio's first product approval.

Regarding Mirataz, the company stated: "The FDA does not have any additional questions or requests from KindredBio, final label negotiations have been completed and all of the required inspections have been completed successfully at the contract manufacturers."

KindredBio will elaborate on its pipeline in its first-quarter results, which will be published on May 8. This is expected to be KindredBio's last quarter before it starts recording revenues. The company posted a net loss of around $31 million during fiscal 2017

Reprinted with permission of Animal Pharm News




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