IHS Global Insight Perspective | |
Significance | Medsafe has released a list of freshly-approved drugs in New Zealand, including Lilly/Daiichi's Effient, Bayer's Xarelto and GSK's Volibris. |
Implications | The marketing of some generic drugs are also among Medsafe's new approvals. |
Outlook | Lilly and Daiichi are to see enhanced profile and sales revenue from Effient's new approval. Xarelto and Volibris are also following on the heels of the regulatory and subsidisation approvals given in the Australian market. |
New Zealand's drug regulator, Medicines and Medical Devices Safety Authority (Medsafe), has granted green lights to a list of new drugs, which was published on the agency's Gazette Notices, dated 6 August and 13 August. The new drugs snatching up Medsafe's nod include blood-thinning treatment Effient/Efient (Eli Lilly, U.S.; Daiichi Sankyo, Japan), German drug major Bayer's antithrombotic drug Xarelto, and GlaxoSmithKline's (GSK, U.K.) pulmonary arterial hypertension (PAH) treatment Volibris. U.S. eyecare specialist Alcon also has two ophthalmologic products, Vexol and Nevanac, approved in New Zealand.
During the same period, Medsafe also approved the marketing of generic drugs including Indian firm Dr. Reddy's anti-psychotic olanzapine, domestic company Douglas Pharma's isotretinoin and Canadian firm Apotex's bicalutamide. They are the generic versions of Eli Lilly's Zyprexa (olanzapine; U.S.), Roche's (Switzerland) acne therapy Isotane and AstraZeneca's (U.K.) oncology drug Casodex.
New Zealand: Selected Drugs Newly-Approved by Medsafe | ||
Name | Active Ingredients | Manufacturer |
Innovative Drugs | ||
Effient | Prasugrel | Eli Lilly/Daiichi Sankyo |
Xarelto | Rivaroxaban | Bayer |
Volibris | Ambrisentan | GSK |
Vexol | Rimexolone | Alcon |
Nevanac | Nepafenac | Alcon |
Generic Drugs | ||
Apo-Bicalutamide | Bicalutamide | Apotex |
Oratane | Isotretinoin | Douglas Pharma |
Olanzapine | Olanzapine | Dr. Reddy's |
Source: Medsafe Gazette Notices, August 2009 | ||
Outlook and Implications
The freshly-granted marketing approval for Effient is one more triumph for Lilly and Daiichi Sankyo following the green lights it has received in key markets including the European Union and the United States (see United States: 13 July 2009: Daiichi Sankyo, Eli Lilly Clinch FDA Nod for Effient, Lilly's Alimta Approved as NSCLC Monotherapy in EU). Effient is therefore to see bolstered sales and market penetration in its global expansion and is due to become an increasingly key drug for the two companies.
Medsafe's okay for Xarelto is also encouraging for Bayer on top of the fact that the company has just been included on the Australia Pharmaceutical Benefit Scheme's (PBS) reimbursement list earlier this month (see Australia: 11 August 2009: Merck's Janumet and Bayer's Xarelto Among Drugs Newly Listed on PBS in Australia). Volibris's approval also followed on the heels of regulatory approval in the neighbouring Australian market.
In terms of drug pricing and reimbursement, the marketing approvals are to be followed by the decision of the country's drug funding regulator Pharmac. It still remains to be seen if the newly-okayed drugs can gain Pharmac's funding and to what extent, which will significantly influence the drugs' sales in the New Zealand market. On the other hand, the generics in the list will constitute considerable threats to their respective innovative versions as well as more expensive drugs already marketed in the same therapeutic groups.