Global Insight Perspective | |
Significance | Sanofi-Aventis's oncology drug Taxotere (docetaxel) will this month receive official approval for a new prostate cancer indication. Approval recommendations have also been made for other drugs, including GlaxoSmithKline's (U.K.) epilepsy drug Lamictal, and for a new atopic dermatitis indication for Novartis's (Switzerland) Neoral. |
Implications | Taxotere had been granted fast-track status, given that it is widely approved for this indication overseas. The new Lamictal and Neoral approval recommendations are significant because, assuming they are acted upon, they will bring new indications to the Japanese market. |
Outlook | Taxotere's imminent approval means that it will have been approved for eight different forms of cancer. Lamictal and Neoral will have to wait at least until September before having their approval recommendations confirmed. |
Taxotere was one of two new approvals that were agreed during a meeting of the Second Committee of Japan's Committees on New Drugs, Pharmaceutical Affairs Section (CDFS), reports Pharma Japan. The other new approval was for a new indication for the antibiotic clarithromycin, which is sold by Taisho (Japan) as Clarith and by Abbott Laboratories (U.S.) as Klaricid. Currently, Clarity/Klaricid is approved for treating mycobacterium avium complex (MAC) associated with AIDS, but this will be changed to non-tuberculosis mycobacteriosis (NTM). For both Taxotere and Clarith/Klaricid, official approval is due to be announced this month.
During the same CDFS meeting, orphan drug status was granted to two HIV drugs that are currently under development in Japan: Pifzer's (U.S.) maraviroc (marketed elsewhere in the world as Celsentri or Selzentry), and Janssen's (U.S.) etrarivine (branded elsewhere as Intelence).
GSK's Lamictal is Among New Approval Recommendations
A previous meeting by the CDFS's First Committee recommended the approval of three new drugs, including GlaxoSmithKline's (U.K.) epilepsy drug Lamictal (lamotrigine). Lamictal was recommended for use in combination with other epilepsy drugs for partial seizures in patients not fully responsive to other drugs, patients with tonic-clonic seizures, and patients with general seizure associated with Lennox-Gastaut syndrome (LGS). The re-examination period was set at eight years.
The other two approval recommendations were for Santen's (Japan) glaucoma/ocular hypertension product Tapros Ophthalmic Solution (tafluprost) and ASKA Pharmaceutical's Menoaid Combipatch (estradiol + norethisterone), which is positioned for treating vasomotor symptoms associated with postmenopausal disorders and ovary deficiency symptoms. Their re-examination periods were set at eight and six years, respectively.
New Atopic Dermatitis Recommendation for Novartis's Neoral
The same CDFS meeting also recommended the approval of additional indications for three drugs, namely Novartis's (Switzerland) immunosuppressant Neoral (ciclosporin), Pfizer's hormone drug Genotropin (somatropin), and Nippon Organon's (Japan) calcium channel blocker Bepricor (bepridil). Neoral was recommended for atopic dermatitis in patients unresponsive to existing treatments; Genotropin was recommended for SGA (small for gestational age) not associated with epiphysiodesis; Bepricor was recommended for persistent atrial fibrillation in patients unresponsive to existing treatments.
For all three drugs, the re-examination period for their new indications was set at four years.
Outlook and Implications
Taxotere's prostate cancer indication had been granted priority review status, given that it is had already been approved with this indication in over 90 countries and is a standard therapy overseas. The drug was previously approved in Japan for seven different forms of cancer—namely breast, head-and-neck, non-small-cell lung, gastric, ovarian, oesophageal, and endometrial cancer (see Japan: 7 June 2007: Japanese MHLW to Review Sanofi-Aventis's Taxotere for Use as Prostate-Cancer Treatment).
In the case of Lamictal, GSK had originally submitted a New Drug Application (NDA) in Japan in 2003, but the application was subsequently withdrawn owing to errors in the compilation of clinical trial data. The drug is indicated for treating partial seizures in adults in 104 countries, partial seizures in children in 93 countries, and Lennox-Gestaut syndrome (LGS) in 50 countries. Assuming the CDFS approval recommendation is followed, Lamictal will be the first drug in Japan to be indicated for LGS.
Neoral's new indication would also represent a first, given that no other oral immunosuppressants are available with an atopic dermatitis indication in Japan. However, this indication for Neoral has already been approved in 67 countries.