R&D
US NME approvals: cancer no longer
reigns supreme
Cancer and HIV medicines took a back seat to constipation and hypertension treatments in the number of
therapeutic new molecular entities and new biologicals approved by the US FDA from November 2007 through
October 2008. The 12-month span also saw some long-delayed medicines fi nally reach commercial fruition
T
he FDA’s drugs and biologicals centres (REMS) that includes a restricted distribution Bystolic was one of two antihypertensives
approved 22 therapeutic NMEs and scheme. Despite the delays, it managed to to clear the agency. The Medicines Company’s
new biologicals, excluding imaging beat GlaxoSmithKline’s rival platelet booster Cleviprex (clevidipine), a short-acting
agents (see Table 1). In contrast to the first 10 Promacta (eltrombopag) to market. Promacta intravenous calcium channel blocker, was
months of 2007, when four new cancer also endured FDAAA-related delays following approved in January. Cleviprex also had its
medicines were approved, Cephalon’s a positive advisory panel review in May, finally share of development problems, encountering
chemotherapeutic agent Treanda securing approval in mid-November. an 18-month delay after the temporary
(bendamustine HCl, licensed from Astellas) Only one new HIV medicine, Tibotec’s suspension of some Phase III trials following
marked the only first-time oncology drug (Johnson & Johnson) non-nucleoside reverse concerns about atrial fibrillation.
approval during the 12-month period analysed. transcriptase inhibitor (NNRTI) Intelence Five of the 22 NMEs and new biologicals
The alkylating agent secured its first approval (etravirine), gained agency clearance during the were evaluated by advisory panels. These were
in March for chronic lymphocytic leukaemia 12-month period. The FDA licensed two new Adolor/GSK’s Entereg; Amgen’s Nplate; Lev
(CLL) and added an indication for relapsed HIV medicines during the first 10 months of Pharmaceuticals’ (now ViroPharma) Cinryze
indolent non-Hodgkin’s lymphoma (NHL) in 2007. (C1 inhibitor (human)), the first product
October. Two NMEs were approved for treating
approved in the US to prevent attacks in
Although the cancer NME approvals were constipation. Wyeth/Progenics’ mu-opioid
people with hereditary angioedema; Prestwick
sparse, several previously approved oncologics receptor antagonist Relistor (methylnaltrexone
Pharmaceuticals’ (now Biovail) chorea
added commercially significant indications. bromide) won approval for treating opioid-
treatment Xenazine (tetrabenazine), the first
Headlining this group was Genentech/Roche’s induced constipation in patients with advanced
US product licensed for any symptom of
anti-angiogenic drug Avastin (bevacizumab), illness receiving palliative care. Adolor/
Huntington’s disease; and Sirion Therapeutics’
which received accelerated approval for locally GlaxoSmithKline’s peripheral mu-opioid
Durezol (difluprednate ophthalmic
recurrent or metastatic breast cancer. Although receptor antagonist Entereg (alvimopan)
emulsion),the first topical corticosteroid
the VEGF inhibitor already carried indications became the first drug indicated for treating
approved for the treatment of both
for colorectal and lung cancer, the breast post-operative ileus.
inflammation and pain associated with ocular
cancer approval was controversial because Entereg has endured despite a troubled
surgery. Tetrabenazine and difluprednate were
Avastin failed to show an overall survival development programme that included
available in overseas markets for decades
benefit in its pivotal study and the agency’s imbalances in serious cardiovascular events,
before entering the US.
oncologic drugs advisory committee narrowly neoplasms and fractures in a large study of
The biologicals centre approved three new
recommended against its use. opioid bowel dysfunction, a more commercially
vaccines during the 12-month period (see
Bayer/Onyx’s oral multi-targeted kinase significant indication. GSK has returned
Table 1), although none was first-in-class or
inhibitor Nexavar (sorafenib), first launched for worldwide rights in the opioid indication to
aimed at addressing previously unmet medical
kidney cancer in 2005, also gained a significant Adolor.
needs. Instead they represented alternative
new indication for liver cancer, becoming the Entereg was one of several novel medicines
formulations and new combinations of existing
first approved systemic therapy for the disease that finally saw the light of day in the US
vaccines.
after improving overall survival. commercial market following a series of
Approved April 3rd, GSK’s Rotarix joined
The FDA’s oncology drug products division developmental setbacks and regulatory delays.
Merck & Co’s Rotateq on the US rotavirus
did sign off on two other new therapeutics: Others on this list included Wyeth’s anti-
vaccine market. Rotarix had the distinction of
Amgen’s thrombopoietin receptor agonist depressant Pristiq (desvenlafaxine), the follow-
being the first product subject to mandatory
Nplate (romiplostim) for chronic immune on agent to Effexor (venlafaxine). FDA approval
postmarketing safety studies under FDAAA.
(idiopathic) thrombocytopenic purpura, and for major depressive disorder came more than
Rotarix and Sanofi Pasteur’s (Sanofi-Aventis)
Roche’s Mircera (methoxy polyethylene glycol- two years after desvenlafaxine’s initial filing
five-in-one paediatric vaccine Pentacel were
epoetin beta) for anaemia associated with owing to compliance problems at Wyeth’s
subject to advisory panel scrutiny. It took
chronic renal failure. Mircera cleared the manufacturing plant and late submission of
Pentacel 17 months to clear the agency
agency in November 2007 but was blocked Phase III data on a lower dose. An indication for
following a positive panel endorsement, with
from launching by a patent dispute with vasomotor symptoms associated with
approval coming almost three years after the
Aranesp (darbepoetin-alfa) marketer Amgen. menopause has been delayed by the FDA’s
original BLA filing.
Nplate received an overwhelming request for an additional clinical trial.
endorsement from the agency’s oncology Approval of Mylan’s beta blocker Bystolic
drugs advisory committee in March, but the (nebivolol) was also a long time coming. Mylan’s
Sue Sutter is Scrip’s
BLA’s April user fee date made it subject to attempts to gain US approval were set back by
Washington editor.
the FDA Amendments Act’s drug safety requests for more data, including an FDA
provisions, which took effect on March 25th. approvable letter in 2005. The company
Nplate finally cleared the agency in mid-August licensed the drug to Forest Laboratories
with a risk evaluation and mitigation strategy in 2006.
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