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Serevent warning re
combination therapy
Serevent warning focuses attention on the need for
combination therapy
The recent announcement by the FDA's
associate director for science and medicine that sales of GlaxoSmithKline's
asthma drug Serevent
should be restricted, or halted, led to an estimated 3.8% fall in the company's
share price. However, Datamonitor's Laura Harris comments that, with
Seretide accounting for
the majority of GSK's asthma sales, the panic may be premature.
During a
senate hearing, convened following the withdrawal of Merck & Co.'s COX-2
Vioxx (rofecoxib) in September, the
FDA's David Graham commented that the safety profile of five other currently
marketed drugs should be closely examined.
Serevent warning focuses attention on the need for
combination therapy
Serevent warning focuses attention on the
need for combination therapy
(Published 10 December 2004)
The
recent announcement by the FDA's associate director for science and medicine
that sales of GlaxoSmithKline's
asthma drug Serevent
should be restricted, or halted, led to an estimated 3.8% fall in the company's
share price. However, Datamonitor's Laura Harris comments that, with Seretide
accounting for the majority of GSK's asthma sales, the panic may be premature.
During a senate hearing, convened following the withdrawal of Merck &
Co.'s COX-2 Vioxx (rofecoxib) in September, the FDA's David Graham commented
that the safety profile of five other currently marketed drugs should be
closely examined. Pfizer's COX-2 Bextra (valdecoxib), similar to
Vioxx, was mentioned, as
were Astra-Zeneca's cholesterol-lowering statin Crestor (rosuvastatin calcium),
Roche's acne treatment Accutane (isotretinoin) and Abbott's weight loss drug
Meridia (sibutramine hydrochloride
monohydrate). It was at the same hearing that Dr Graham raised concerns
about GSK's asthma inhaler Serevent (salmeterol).
Beta2-agonists
called into question
Although widely used for over a decade,
Serevent has come under fire in recent years due to the results of a GSK
sponsored safety study, known as SMART (Salmeterol Multi-center Asthma Research
Trial). Initiated in July 1996, SMART was designed to assess the adverse
effects of Serevent, following concerns regarding the safety of regular use of
short-acting and long-acting beta2-agonists in the management of asthma.
Interim analysis in late 2002 found that there was an increased
incidence of life-threatening asthma related events, particularly in the
African-American population. In the salmeterol group, there were a total of 13
deaths out of 13,174 patients treated for 28 weeks, or 0.1%, versus 0.03% (4 of
13,179) for those on a placebo.
Consequently, a black box warning was
added to the Serevent US product labeling in August 2003. This stated that data
from a large, placebo-controlled, US study comparing the safety of salmeterol
or placebo, added to usual asthma therapy, showed a small but significant
increase in asthma-related deaths. Indeed, this may have had a negative impact
on US sales - while 10% growth was recorded between 2000 and 2001, sales fell
in subsequent years, by 26% between 2001 and 2002, and 36% in 2002-2003.
Superior safety of Seretide
However, the majority of
sales erosion can be attributed to the 2001 launch of GSK's combination asthma
product, Seretide (salmeterol/fluticasone) in
the US. The drug, which is known as Advair in the US, combines Serevent with
GSK's inhaled corticosteroid Flixotide (fluticasone) in a Diskus inhaler.
Seretide is currently the best selling asthma product, generating $3.2 billion
of sales in the seven major markets in 2003. Although a key part of Seretide's
appeal is its simple administration and convenience in enabling patients to
take two asthma therapies simultaneously, the improved safety profile of
salmeterol when administered concomitantly with a corticosteroid adds to
Seretide's appeal.
Current
asthma
guidelines (National Asthma Education and Prevention Program) recommend
that patients requiring more than as-needed short-acting beta2-agonists should
be prescribed regular and adequate doses of an inhaled anti-inflammatory asthma
medication, such as inhaled corticosteroids, for optimal benefit in the
management of their asthma.
Although there was a low level of inhaled
corticosteroid use in SMART, at 47% of the study population, data demonstrated
that, in these patients, there were no significant differences in primary and
asthma related adverse events, including death. In contrast, in patients who
did not receive inhaled corticosteroids, there were a statistically significant
greater number of asthma-related deaths in all patients taking salmeterol
compared to those taking the placebo.
Serevent sales to suffer
In light of this data, and the current recommendations for combination
therapy if using a long-acting beta2-agonist (LABA) such as salmeterol,
Seretide is likely to experience continued market success. This will be at the
expense of Serevent, which, following the FDA's comments last week, is likely
to be infrequently used alone and will, therefore, suffer greater sales
erosion.
However, if GSK can ensure continued patient switching to
Seretide, the company's
overall respiratory sales are unlikely to suffer and may actually increase as
patients and physicians recognize the added convenience of Seretide.
Furthermore, the Diskus is less expensive than the two monotherapies,
conferring an additional benefit. As long as GSK can separate the public's
perception of Seretide/Advair from that of Serevent, a sizeable task given the
similarity of the products, it is likely that the initial panic caused by the
FDA's comments will be relatively short-lived.
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