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Wyeth's Relistor, GSK's Volibris Among 11 Drugs Recommended for Approval by ADEC
18 Nov 08
ADEC's approval recommendations give Wyeth's Relistor, GSK's Volibris, and Bayer's Xarelto, together with eight other drugs, imminent marketing opportunities in Australia.
Global Insight Perspective | | Significance | The Australian Drug Evaluation Committee (ADEC) has made approval recommendations for eight new drugs, and for three already-marketed drugs with indication expansions. | Implications | ADEC's latest meeting has made approval recommendations for the largest groups of new drugs so far this year. This will add a considerable amount of new drugs to the Australian market. | Outlook | In addition to competition with the already-on-sale drugs in relevant treatment fields, drugs like Bayer's Xarelto and Boehringer Ingelheim's Pradaxa will also compete between themselves for anti-thrombotic market share. In terms of the PBS listing, the drugs need over one year under the current process; however, the recently-proposed faster PBS listing process, if it comes into effect soon, may shorten the waiting time. |
Resolutions on 11 approval recommendations from ADEC's latest meeting have recently been published in the Commonwealth of Australia Gazette. U.S company Wyeth's Relistor (methylnaltrexone) and GSK (U.K.)'s Volibris (ambrisentan) are among the recommended drugs with indications for opioid-induced constipation and pulmonary arterial hypertension respectively. HIV-1 drug Intelence (etravirine, Janssen Cilag, U.S.) and anti-thrombotic drugs Xarelto (rivaroxaban, Bayer, Germany) and Pradaxa (dabigatran, Boehringer Ingelheim, Germany) are also on the list. U.K. pharma company AstraZeneca's Seroquel (quetiapine), currently marketed in Australia as a schizophrenia treatment, has received approval recommendation for new indications of bipolar-1 disorder maintenance treatment and acute mania associated with bipolar-1 disorder. Eli Lilly's (U.S.) osteoporosis drug Evista (raloxifene) has been recommended for the new indication of invasive breast cancer. ADEC Recommendations for Approval | Drug | Active Ingredient | Producer | Indication | Relistor | methylnaltrexone | Wyeth, U.S. | Opioid-induced constipation | Volibris | ambrisentan | GSK, U.K. | Pulmonary arterial hypertension | Seroquel | quetiapine | AstraZeneca, U.K | Bipolar-1 disorder maintenance treatment, acute mania associated with bipolar-1 disorder | Intelence | etravirine | Janssen-Cilag, U.S. | HIV-1 infection | Clexane/Lovenox | enoxaparin | Sanofi–Aventis, France | Acute ST-segment elevation myocardial infarction | Angiomax | bivalirudin | CSL, Australia | Acute coronary syndromes, percutaneous coronary intervention | Xarelto | rivaroxaban | Bayer, Germany | Venous thrombosis | Evista | raloxifene | Eli Lilly, U.S. | Invasive breast cancer | Bridion | sugammadex | Organon, Australia | Neuromuscular blockade | Pradaxa | dabigatran | Boehringer Ingelheim, Germany | Venous thrombosis | Cubicin | daptomycin | Novartis, Switzerland | Complicated skin and skin structure infections; Staphylococcus aureus bloodstream infections |
Outlook and Implications Wyeth has gained worldwide development and marketing rights of Relistor from U.S. firm Progenics apart from Japan, where Japanese drug firm Ono has the rights (see Japan: 17 October 2008: Ono Pharmaceutical Snaps Up Japanese Rights to Relistor). Wyeth received the green light to sell Relistor in the United States and European markets earlier this year. The approval in Australia will give the drug's worldwide sales a further boost. GSK's Volibris, approved in Europe in February for pulmonary arterial hypertension treatment, is going to make up for some losses the company is going to suffer from PBS's delisting of its anti-diabetes Avandia products (see Australia: 4 November 2008: GSK's Avandia Products Face PBS De-Listing). Meanwhile, another U.K. drug firm AstraZeneca's Seroquel has the approval recommendation following the recent PBS-listing of its Seroquel XR (see Australia: 11 November 2008: Seroquel XR Listed on PBS). On the other hand, the imminent marketing of the 11 drugs in Australia will add competition with drugs already in the relevant fields, as well as among drugs in the latest list. Bayer's Xarelto and Boehringer Ingelheim's Pradaxa will inevitably fight for the anti-thrombotic markets. Under the current process, it could take these drugs as long as 12 to 18 months after the Therapeutic Goods Administration (TGA) approval to be listed on the Pharmaceutical Benefits Scheme (PBS) for government reimbursement. However, there is a chance for earlier PBS listing if the recently-proposed accelerated PBS listing process comes into effect soon (see Australia: 6 May 2008: Faster Drug Approvals to Be Considered in Australia).
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