Date: October 30, 2012
For Release: Immediately
Refer to: Teresa Shewman, +1
(317) 433-1888 (office), +1 (317) 292-8940 (mobile),
shewmante@lilly.com
European Commission approves Cialis® (tadalafil) tablets for the
treatment
of the signs and symptoms of benign prostatic hyperplasia
Cialis becomes only medication approved in the EU for both
erectile dysfunction
and signs and symptoms of benign prostatic hyperplasia
INDIANAPOLIS (October 30, 2012) - Eli Lilly and Company (NYSE:
LLY) announced today that the European Commission has approved
Cialis 5 mg for once daily use for the treatment of the signs and
symptoms of benign prostatic hyperplasia (BPH).
Cialis was approved for erectile dysfunction (ED) in the EU in
2002. Cialis for once daily use was approved to treat ED in the EU
in 2007.
"With this approval, Cialis is now the only medication in the EU
to provide a single treatment option for men with both ED and BPH,"
said Anthony Beardsworth, senior
medical director at Lilly. "Since many men who have ED also
experience the signs and symptoms of BPH, a single medication
approved to treat both may be a useful therapeutic option for men
and physicians."
Cialis 5 mg for once daily use was approved by the U.S. Food and
Drug Administration (FDA) in October
2011 for the treatment of the signs and symptoms of BPH. The
FDA also approved Cialis 5 mg for once daily use to treat men who
have both erectile dysfunction and the signs and symptoms of benign
prostatic hyperplasia (ED+BPH).
In addition to the U.S. and EU, Cialis for once daily use has
been approved to treat the signs and symptoms of BPH in
Canada, Mexico, Brazil, South
Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa
Rica, Colombia and
Israel.
It is important to note that Cialis is not to be taken with
medicines called "nitrates" such as isosorbide dinitrate or
isosorbide mononitrate, which are often prescribed for chest pain,
or with recreational drugs called "poppers" like amyl or butyl
nitrite, as the combination may cause an unsafe drop in blood
pressure. It also should not be taken by those who are allergic to
Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone
who experiences any symptoms of an allergic reaction, such as rash,
hives, swelling of the lips, tongue or throat, or difficulty
breathing or swallowing should call their healthcare provider or
get help right away.
About ED and BPH
ED is a condition where the penis does not fill with enough
blood to harden and expand when a man is sexually excited, or when
he cannot keep an erection. Approximately 50 percent of men between
40-70 years old have ED.
BPH is a condition where the prostate enlarges, which can cause
urinary symptoms. Common symptoms of BPH include:
* Needing to go frequently or urgently
* Stopping or starting during urination
* Needing to push or strain during urination
* Having a weak urine stream
* Incomplete emptying of the bladder
* Nocturia, or needing to go excessively at night
ED and BPH are conditions that may occur in the same patient.
Several studies have shown that many men with ED also experience
the symptoms of BPH.,,
About Cialis
Cialis is currently approved for ED in more than 100 countries
throughout the world.
In the United States, Cialis
provides men with ED two different dosing options - Cialis for once
daily use (2.5 mg and 5 mg) and Cialis for use as needed (5 mg, 10
mg and 20 mg). Cialis is not to be taken more than one time each
day.
Cialis for once daily use is approved to treat ED, the signs and
symptoms of BPH, and ED and the signs and symptoms of BPH in men
who have both conditions (ED+BPH). Cialis 5 mg for once daily use
is the recommended dose to treat BPH and ED+BPH.
Cialis for once daily use can help men with ED be ready anytime
between doses*, so they do not have to plan sexual activity around
taking a pill. It can also treat the signs and symptoms of BPH.
Cialis for once daily use is the only medication approved to treat
both ED and the signs and symptoms of BPH.
Cialis for use as needed is approved to treat erectile
dysfunction (ED). Cialis for use as needed should be taken before
sexual activity. It may go to work quickly (in as little as 30
minutes in some men) and can work up to 36 hours.*†
The most common side effects with Cialis are headache,
indigestion, back pain, muscle aches, flushing and stuffy or runny
nose. These side effects usually go away after a few hours. Men who
get back pain and muscle aches usually get it 12 to 24 hours after
taking Cialis. Back pain and muscle aches usually go away within
two days.
*Individual results may vary. Not studied for multiple attempts
per dose. †In clinical trials, Cialis for use as needed started to
work in 30 minutes for some men who took 20 mg of Cialis for use as
needed. When taken as needed, Cialis was shown to improve, up to 36
hours after dosing, the ability of men with ED to have a single
successful intercourse attempt.
Important Safety Information for Cialis® (tadalafil) tablets
What Is The Most Important Information I Should Know About
Cialis?
Do not take Cialis if you:
* take medicines called "nitrates" such as isosorbide dinitrate or isosorbide
mononitrate which are often prescribed for chest pain as the combination
may cause an unsafe drop in blood pressure
* use recreational drugs called "poppers" like amyl nitrite and butyl nitrite
* are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients.
Call your healthcare provider or get help right away if you experience any
symptoms of an allergic reaction, such as rash, hives, swelling of the
lips, tongue or throat, or difficulty breathing or swallowing
After taking a single tablet, some of the active ingredient of
Cialis remains in your body for more than 2 days. The active
ingredient can remain longer if you have problems with your kidneys
or liver, or you are taking certain other medications.
Stop sexual activity and get medical help right away if you get
symptoms such as chest pain, dizziness, or nausea during sex.
Sexual activity can put an extra strain on your heart, especially
if your heart is already weak from a heart attack or heart
disease.
What Should I Tell My Healthcare Provider Before Taking
Cialis?
Cialis is not right for everyone. Only your healthcare provider
and you can decide if Cialis is right for you. Ask your healthcare
provider if your heart is healthy enough for you to have sexual
activity. You should not take Cialis if your healthcare provider
has told you not to have sexual activity because of your health
problems. Before taking Cialis, tell your healthcare provider about
all your medical problems, particularly if you have or ever
had:
* heart problems such as chest pain (angina), heart failure, irregular
heartbeats, or have had a heart attack
* high or low blood pressure or have high blood pressure that is not
controlled
* stroke
* liver or kidney problems or require dialysis
* retinitis pigmentosa, a rare genetic (runs in families) eye disease
* severe vision loss, including a condition called NAION
* stomach ulcers or a bleeding problem
* a deformed penis shape or Peyronie's disease
* an erection that lasted more than 4 hours
* blood cell problems such as sickle cell anemia, multiple myeloma, or
leukemia
Can Other Medicines Affect Cialis?
Tell your healthcare provider about all the medicines you take
especially if you take:
* medicines called "nitrates" which are often prescribed for chest pain
* alpha-blockers often prescribed for prostate problems
* blood pressure medications
* medicines for HIV or some types of oral antifungal medications
* some types of antibiotics such as clarithromycin, telithromycin,
erythromycin (several brand names exist, please contact your healthcare
provider to determine if you are taking this medicine)
* other medicines or treatments for erectile dysfunction (ED)
* Cialis is also marketed as Adcirca for the treatment of pulmonary arterial
hypertension. Do not take both Cialis and Adcirca. Do not take sildenafil
citrate (Revatio®)* with Cialis.
What Should I Avoid While Taking Cialis?
* Do not use other ED medicines or ED treatments while taking Cialis.
* Do not drink too much alcohol when taking Cialis (for example, 5 glasses of
wine or 5 shots of whiskey). Drinking too much alcohol can increase your
chances of getting a headache or getting dizzy, increasing your heart rate,
or lowering your blood pressure.
What Are The Possible Side Effects Of Cialis?
The most common side effects with Cialis are: headache,
indigestion, back pain, muscle aches, flushing, and stuffy or runny
nose. These side effects usually go away after a few hours. Men who
get back pain and muscle aches usually get it 12 to 24 hours after
taking Cialis. Back pain and muscle aches usually go away within 2
days. Call your healthcare provider if you get any side effect that
bothers you or one that does not go away.
Uncommon but serious side effects include:
An erection that won't go away: If you get an erection lasting
more than 4 hours, seek immediate medical help to avoid long-term
injury.
In rare instances, men taking prescription ED tablets, including
Cialis, reported a sudden decrease or loss of vision or hearing
(sometimes with ringing in the ears and dizziness). It's not
possible to determine if these events are related directly to the
ED tablets or to other factors. If you have a sudden decrease or
loss of vision or hearing, stop taking any ED tablet, including
Cialis and call a healthcare provider right away.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Cialis does not:
* cure ED
* increase a man's sexual desire
* protect a man or his partner from sexually transmitted diseases, including
HIV
* serve as a male form of birth control
Cialis is available by prescription only. For additional
information, talk to your doctor and see full Patient Information
at http://pi.lilly.com/us/ cialis-ppi.pdf and Prescribing
Information at http://pi.lilly.com/us/ cialis-pi.pdf, or visit
www.cialis.com for more information.
* The brand listed is a trademark of its respective owner and is
not a trademark of Eli Lilly and Company. The maker of this brand
is not affiliated with and does not endorse Eli Lilly and Company
or its products.
TD Con-F ISI 03FEB2012
About Eli Lilly and Company Lilly, a leading innovation-driven
corporation, is developing a growing portfolio of pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs.
This press release contains forward-looking statements about the
potential of Cialis for the treatment of signs and symptoms of
benign prostatic hyperplasia (BPH) and reflects Lilly's current
beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development,
commercialization, and regulatory review. There is no guarantee
that Cialis will receive additional regulatory approvals. There is
also no guarantee that Cialis will continue to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
TD81237
P-LLY
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
1 Feldman HA et al. Impotence and its medical and psychosocial
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2 Rosen R, Altwein J, Boyle P, Roger SK, Lukacs B, Meuleman E,
et al. Lower urinary tract symptoms and male sexual dysfunction:
the multinational survey of the aging male (MSAM-7). Eur Urol.
2003;44(6):637-649.
3 Brookes ST, Link CL, Donovan JL, and McKinlay JB. Relationship
between lower urinary tract symptoms and erectile dysfunction:
results from the Boston Area
community Health Survey. J Urol 2008;179:250-255.
4 Gacci M, et al. Critical analysis of the relationship between
sexual dysfunctions and lower urinary tract symptoms due to benign
prostatic hyperplasia. Eur Urol 2011; 60:809-825.
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