Atozet latecomer CKD Atoezy wins approval without PMS

RMP to replace post-marketing use-result surveillance, accurate release date unknown

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Chong Kun Dang has reportedly received the South Korean health authority’s approval on a follow-on drug of MSD’s dyslipidemia treatment Atozet.

 

The approval preceded Atozet’s post-marketing surveillance (PMS) end date on Jan.

 

22 next year by three months, putting the latecomer on an advantageous position.

 

However, the estimated launch date is still unknown as the South Korean company is to call for a CMO to manufacture the same substance drug.

 

Chong Kun Dang’s Atoezy is not pressured to meet the PMS conditions as Atozet’s outstanding PMS period did not carry over.

 

On Oct.

 

13, the Ministry of Food and Drug Safety (MFDS) green lit three doses of Atoezy by Chong Kun Dang.

 

The drug shares the same substance (atorvastatin calcium hydrate plus ezetimibe) as Atozet.

 

But Atoezy dropped the hydrate but contains atorvastatin calcium, instead.

 

In a Phase 1 trial, the Korean drug proved the bioequivalence to its reference drug, Lipitor plus Ezetrol.

 

And also it confirmed statistically significant reduction of low-density lipoprotein cholesterol (LDL-C) level in a group taking the drug against the control group during a Phase 3 trial conducted on 366 patients with primary dyslipidemia for eight to 12 weeks.

 

Although it was predicted the outstanding PMS would be carried over to the Korean drug as it shares the same substance with Atozet, MFDS designated the drug as a subject to submit risk management plan (RMP) to verify its safety after the market release.

 

Similar to PMS, RMP subjects have to hand in use-result surveillance outcomes after the market release.

 

But for pharmaceutical companies, PMS could feel more burdensome as a certain period of use-result surveillance is set as an approval condition.

 

For instance, it would have been almost impossible for Atoezy to meet the 600 cases of use-result surveillance until Jan.

 

22 next year to apply Atozet’s outstanding PMS.

 

MFDS official explained the condition was replaced with RMP as the outstanding PMS period was only three months and the ministry has a precedent to refer to.

 

As Atoezy was able to dodge the outstanding PMS carryover, consigned companies that applied for authorized generic approval last month seem to be relieved.

 

Atoezy would be able to launch the product in January next year at earliest.

 

But the Korean company could be releasing the product around April next year, as the company has reportedly agreed with consigned companies to release the product along with authorized generic.

 

Even if the launch date gets scheduled in next April, it would be still earlier than other generics entering the market after Atozet’s PMS period.

 

Moreover, the industry is unsure of Chong Kun Dang directly handling the sales, as the Korean company has been co-marketing MSD’s original drug Atozet.

 

Some speculates Atoezy’s license could be transferred to other company.