CHMP Recommends One New Drug, Begins Review of Indian CRO

Regulatory NewsRegulatory News | 28 February 2020 |  By 

At its meeting earlier this week the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended one new and one generic medicine for authorization and launched a review of medicines supported by an Indian contract research organization (CRO) citing data integrity concerns.
Specifically, CHMP recommended the authorization of Shionogi’s Fetroja (cefiderocol) to treat Gram-negative bacterial infections and Accord Healthcare’s generic version of the antibiotic tigecycline. The recommendation for Fetroja comes after the US Food and Drug Administration approved the drug to treat certain complicated urinary tract infections caused by Gram-negative bacteria last November.
The EU committee also backed extended indications for Takeda’s Alunbrig (brigatinib), Boehringer Ingelheim’s Ofev (nintedanib) and Amgen’s Otezla (apremilast) and issued a negative opinion for extending the indication of Eli Lilly’s Emgality (gelcanezumab) to prevent episodic cluster headaches in adults.
Article 31 and Article 20 Reviews
CHMP says it is reviewing medicines on the EU market that were supported by studies conducted by Indian CRO Panexcell Clinical Laboratories Priv. Ltd after German and Austrian authorities raised concerns about the reliability of studies conducted by the company.
Following an inspection in October, Austria’s Federal Office for Safety in Health Care (BASG) and Germany’s Federal Institute of Drugs and Medical Devices (BfArM) said that the pharmacokinetic profiles of several participants in a bioequivalence trial for the chemotherapy drug doxorubicin were too similar to have occurred by chance.
“The severity and the extent of the findings of the inspection of BASG and BfArM raise serious concerns relating to the suitability of the quality management system at Panaxcell … and about the overall reliability of data generated by this CRO,” according to the Article 31 referral letter from Germany.
The letter also says that inspectors observed Panexcell personnel intentionally documenting the wrong room temperature “to pretend that room temperature in the sample processing area was within the acceptance range.”
The referral follows several others in recent years involving data integrity issues at Indian CROs and generic drugmakers.
CHMP also says it is reviewing Pharma Mar’s ovarian cancer and soft-tissue sarcoma cancer drug Yondelis (trabectedin) after a recent study of the drug was discontinued early when an interim analysis found that Yondelis plus pegylated liposomal doxorubicin (PLD) did not extend survival compared to PLD alone.
“EMA will therefore review the available data to asses whether the results from study OVC-3006 have an impact on the authorized use of Yondelis in patients with ovarian cancer,” the agency writes, noting that the review does not extend to the use of Yondelis to treat soft-tissue sarcoma.


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