For the second time in recent weeks, a new drug application has been rejected by the FDA over a manufacturing issue. The most recent is a doozy because it is for the hyperkalemia drug AstraZeneca was hot for when it ponied up $2.7 billion to buy ZS Pharma.
In an announcement Friday, AstraZeneca ($AZN) said the FDA issued a Complete Response Letter (CRL) for the ZS-9 NDA, a kidney drug that analysts expected to be a blockbuster. “The CRL refers to observations arising from a pre-approval manufacturing inspection,” the U.K. drugmaker said in a statement.
The company said that it will work closely with the FDA to figure out its next steps and that the agency had acknowledged it has yet to review some additional data from the company about that it had yet to review.
AstraZeneca told FierceBiotech on Friday that the “recently submitted data” were “additional supportive data for the application [which] was very much proactively done in order to support our application.”
The company was eager to point out that the FDA is not asking for more trials or additional clinical data. “I think it’s important to note that we have not been asked to undertake new trials. The underlying efficacy and benefits are there. But let’s not pretend this is not ideal and it’s disappointing that the manufacturing issues are there.”
The AstraZeneca spokesman said that the manufacturing problems were from the ZS Pharma unit. “We’re working through these issues and we remain absolutely confident in the asset itself and ZS Pharma. We will be putting the full resources of AstraZeneca's global manufacturing power behind ZS Pharma to resolve the issues.” He said that this will be done in “as timely a manner as possible” and that there is a “clear plan in place.”
He said the company would resubmit its application as the issues are resolved and that there would probably be a 6-month review period, delaying but not in any way derailing the launch of the drug.
At the end of March, Miami-based OPKO ($OPK) received a CRL because of issues the FDA had with the manufacturing plant in Florida where its drugs are being manufactured by Catalent ($CTLT), OPKO's CMO. In that case, OPKO pointed out the FDA had general concerns with the plant and not with the manufacturing of Rayaldee, OPKO's treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
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