Opko extended-release kidney disease drug approved after Catalent 483 delay

By Dan Stanton

- Last updated on GMT

Rayaldee is made at Catalent's St. Petersburg, Florida softgel plant
Rayaldee is made at Catalent's St. Petersburg, Florida softgel plant

Related tags Food and drug administration

The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

“Observations of deficiencies at Opko’s third-party contract manufacturer”​ were cited by the US Food and Drug Adminitration (FDA) in March, as part of a complete response letter (CRL) which put approval of the firm’s extended-release drug Rayaldee (calcifediol) on hold.

The contract manufacturer was Catalent, which received a Form 483 with 14 observations​ at its facility in St. Petersburg, Florida, following an inspection by the Agency, but the firm has confirmed the issues have been rectified, leading to Opko announcing yesterday Rayaldee has now been approved by the FDA.

“Catalent submitted a comprehensive response to the FDA’s observations on April 15, 2016 as scheduled,”​ a spokesperson from the contract development and manufacturing organisation (CDMO) told this publication.

“The company was already implementing measures to address some of the areas noted in the FDA observations prior to submitting its response, and the FDA accepted Catalent’s full response in May, indicating it would take no further action.”

Rayaldee is an extended release drug made using Catalent’s OptiShell softgel delivery platform technology. The spokesperson could not divulge when asked the volume of Rayaldee it will produce for Opko, due to client confidentiality.

But according to Opko CEO Charles Bishop, Catalent has sufficient capacity for its expected demand and - despite the regulatory delay - the firm is still on target to launch Rayaldee in the second half of 2016. He also told us it has no doubts about the quality at its CMO partner.

"Catalent is the largest softgel producer in the world and the facility Rayaldee is being made at is Catalent’s second largest of their 31 facilities.  We believe that Catalent is an excellent partner and receiving 483’s is a normal course business issue."

Catalent's quality commitment

The observations cited by the FDA in March included Catalent’s failure to investigate the presence of foreign dark matter in a gel receiver, failure to ensure equipment and utensils were cleaned and maintained at appropriate intervals to prevent contamination, and issues with laboratory and control systems.

“Catalent is deeply committed to ensuring the highest level of quality and regulatory compliance, and harnessed its extensive global resources and expertise to ensure all relevant processes, training and oversight at the site met or exceeded all applicable regulatory standards,”​ the firm told us.

The news comes six weeks after the CDMO was given the regulatory all clear​ at another softgel facility, in Beinheim, France, five months after the discovery of out-of-place capsules led French authorities to suspend operations at the site, costing the firm upwards of $30m in lost revenues. 

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