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Half of 2017 TGA drug approvals over time
Posted 7 February 2018
While the TGA has averaged 220 working days to review new drug dossiers in 2017 - 35 days less than legally required - the number of days taken by sponsors in the evaluation process has blown the time out by on average seven weeks.
According to a Pharma in Focus analysis of the TGA's annual summary of prescription medicines and biologicals, which gives dates for the commencement of an evaluation and final TGA approval, 17 of the 34 new drugs ARTG registered last year took longer than 255 days to reach TGA approval following commencement, while the other half came in under.
On average, the total timeframe taken by a drug to be approved was 255 working days, with the extra seven weeks added to the TGA's review time attributed to time when the dossiers were with sponsors.
The regulator itself stated in its report that, on its end, "all products were approved within the statutory 255 working day period", with the review time at its end ranging from 161 to 238 days.
"When the overall approval period exceeded 12 calendar months, this was for a range of reasons, including extended periods for sponsor responses, or appeals of an initial decision by TGA, followed by sponsors providing further information," it said.
The drug which took the longest to reach approval was Servier's Lonsurf, with the total timeframe being around 337 working days* between evaluation commencement and ARTG registration, suggesting the application was back with Servier for at least 82 days, or 16 weeks.
Lonsurf was finally registered in May for the treatment of metastatic colorectal cancer.
The next longest was Pfizer's meningococcal B Vaccine Trumenba, which took around 292 working days, and Amicus' Fabry disease therapy Galafold, taking around 289 working days.
New drugs which cruised through the evaluation process fastest included Janssen's multiple myeloma treatment Darzalex, the quickest drug to registration at 160 working days, while Sanofi's high-dose flu vaccine Fluzone took just 195 days.
Both sponsors were also speedy when it came to getting their drugs to the PBAC, with Darzalex submitted to the November meeting only to be rejected, and Fluzone numbered among the list of those being considered in the PBAC meeting next month.
AbbVie's Venetoclax was also quick, taking 207 working days to registration for chronic lymphocytic leukaemia.
In terms of sponsors with the most ARTG registrations, Roche was a big winner, received the green light for Ocrevus, Alcensa, and Tecentriq over the course 2017.
Sanofi, Pfizer, CSL, Novo Nordisk and Mayne all had two new drugs ARTG registered over the year.
ARTG extensions slightly faster
Extended uses of existing ARTG registered medicines had a slightly quicker timeframe to ARTG-registration than completely new drugs, with the average of the 46 extended applications coming in at around 245 working days.
This speediness may be due to the range of extended applications submitted to the regulator covering everything from new doses and age populations to new indications.
One of the quickest extended applications granted was for MSD's Keytruda in NSCLC, with PD-L1 inhibitor's application taking around 110 working days to go through the review process, although an application for first-line use of the same drug in the same indication was also being processed at the time, perhaps explaining its speedy timeframe.
GSK's four-strain Menveo vaccine was the fastest of the extension applicants, coming in at just 99 working days from evaluation commencement to registration decision.
Yajun Ma
* Public holidays were not taken into account in calculating the number of working days in which applications were assessed. Total time includes time when applications were with sponsors as well as with the TGA. The TGA is required to assess applications within 255 working days, which does not include days applications are with sponsors.
Posted 7 February 2018
While the TGA has averaged 220 working days to review new drug dossiers in 2017 - 35 days less than legally required - the number of days taken by sponsors in the evaluation process has blown the time out by on average seven weeks.
According to a Pharma in Focus analysis of the TGA's annual summary of prescription medicines and biologicals, which gives dates for the commencement of an evaluation and final TGA approval, 17 of the 34 new drugs ARTG registered last year took longer than 255 days to reach TGA approval following commencement, while the other half came in under.
On average, the total timeframe taken by a drug to be approved was 255 working days, with the extra seven weeks added to the TGA's review time attributed to time when the dossiers were with sponsors.
The regulator itself stated in its report that, on its end, "all products were approved within the statutory 255 working day period", with the review time at its end ranging from 161 to 238 days.
"When the overall approval period exceeded 12 calendar months, this was for a range of reasons, including extended periods for sponsor responses, or appeals of an initial decision by TGA, followed by sponsors providing further information," it said.
The drug which took the longest to reach approval was Servier's Lonsurf, with the total timeframe being around 337 working days* between evaluation commencement and ARTG registration, suggesting the application was back with Servier for at least 82 days, or 16 weeks.
Lonsurf was finally registered in May for the treatment of metastatic colorectal cancer.
The next longest was Pfizer's meningococcal B Vaccine Trumenba, which took around 292 working days, and Amicus' Fabry disease therapy Galafold, taking around 289 working days.
New drugs which cruised through the evaluation process fastest included Janssen's multiple myeloma treatment Darzalex, the quickest drug to registration at 160 working days, while Sanofi's high-dose flu vaccine Fluzone took just 195 days.
Both sponsors were also speedy when it came to getting their drugs to the PBAC, with Darzalex submitted to the November meeting only to be rejected, and Fluzone numbered among the list of those being considered in the PBAC meeting next month.
AbbVie's Venetoclax was also quick, taking 207 working days to registration for chronic lymphocytic leukaemia.
In terms of sponsors with the most ARTG registrations, Roche was a big winner, received the green light for Ocrevus, Alcensa, and Tecentriq over the course 2017.
Sanofi, Pfizer, CSL, Novo Nordisk and Mayne all had two new drugs ARTG registered over the year.
ARTG extensions slightly faster
Extended uses of existing ARTG registered medicines had a slightly quicker timeframe to ARTG-registration than completely new drugs, with the average of the 46 extended applications coming in at around 245 working days.
This speediness may be due to the range of extended applications submitted to the regulator covering everything from new doses and age populations to new indications.
One of the quickest extended applications granted was for MSD's Keytruda in NSCLC, with PD-L1 inhibitor's application taking around 110 working days to go through the review process, although an application for first-line use of the same drug in the same indication was also being processed at the time, perhaps explaining its speedy timeframe.
GSK's four-strain Menveo vaccine was the fastest of the extension applicants, coming in at just 99 working days from evaluation commencement to registration decision.
Yajun Ma
* Public holidays were not taken into account in calculating the number of working days in which applications were assessed. Total time includes time when applications were with sponsors as well as with the TGA. The TGA is required to assess applications within 255 working days, which does not include days applications are with sponsors.
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