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TGA fast track boasts nine drugs
Posted 25 January 2018
Another three drugs have received Priority Review designations, bringing the total number of tickets to nine since the first was handed to Roche's Alecensa last August.
Janssen's Erleada was the first priority designation of the year, receiving the ticket last week for treatment of patients with castration-resistant prostate cancer at risk of developing metastases.
The drug, which has not yet been approved in any jurisdiction, was filed in the US last October with Janssen stating it would be the first therapy available for pre-metastatic prostate cancer if it receives an approval from the regulator.
Last December Novartis' Tafinlar and Mekinist, which were indicated for use together as an adjuvant therapy for patients with resected BRAF V600 melanoma, also received two separate priority designations from the TGA.
The combination therapy is listed on the PBS for the unresectable form of BRAF V600 melanoma. It has not been approved anywhere for the adjuvant setting, with the Australian priority designation handed down around the same time as the FDA's speedy tag last December.
The numbers predict a fairly busy year ahead for the new program, especially as drugs potentially filed with priority review designations attached are expected to receive first ARTG registrations in the first half of the year.
Priority review designations do not necessarily mean companies have filed the drug with the TGA, however the tags lapse within six months of being granted, meaning sponsors must file before then to make use of the expedited track.
Also on the TGA's designation page was an orphan drug designation granted to Vertex's Symdeko for treatment of cystic fibrosis. Under the new orphan drug program, these designations also lapse within six months of granting, meaning sponsors must file before then to take advantage of the ticket.
Yajun Ma
Posted 25 January 2018
Another three drugs have received Priority Review designations, bringing the total number of tickets to nine since the first was handed to Roche's Alecensa last August.
Janssen's Erleada was the first priority designation of the year, receiving the ticket last week for treatment of patients with castration-resistant prostate cancer at risk of developing metastases.
The drug, which has not yet been approved in any jurisdiction, was filed in the US last October with Janssen stating it would be the first therapy available for pre-metastatic prostate cancer if it receives an approval from the regulator.
Last December Novartis' Tafinlar and Mekinist, which were indicated for use together as an adjuvant therapy for patients with resected BRAF V600 melanoma, also received two separate priority designations from the TGA.
The combination therapy is listed on the PBS for the unresectable form of BRAF V600 melanoma. It has not been approved anywhere for the adjuvant setting, with the Australian priority designation handed down around the same time as the FDA's speedy tag last December.
The numbers predict a fairly busy year ahead for the new program, especially as drugs potentially filed with priority review designations attached are expected to receive first ARTG registrations in the first half of the year.
Priority review designations do not necessarily mean companies have filed the drug with the TGA, however the tags lapse within six months of being granted, meaning sponsors must file before then to make use of the expedited track.
Also on the TGA's designation page was an orphan drug designation granted to Vertex's Symdeko for treatment of cystic fibrosis. Under the new orphan drug program, these designations also lapse within six months of granting, meaning sponsors must file before then to take advantage of the ticket.
Yajun Ma
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