Eli Lilly spikes as FDA approves label change for diabetes..

[mannmade]

www.yahoo.com/finance/news/eli-lilly-spikes-fda-approves-212305055.html

Health
Eli Lilly spikes after FDA approves label change for diabetes drug to reduce cardiovascular death
Christine Wang,CNBC Fri, Dec 2 1:23 PM PST

Eli Lilly (LLY) shares climbed amid a volume spike after the Food and Drug Administration approved a label change for a diabetes drug the company markets with German pharmaceutical company Boehringer Ingelheim.

The stock gained more than 2 percent as more than 12.2 million shares changed hands, well above its 30-day average volume of 6.9 million shares.

Jardiance had already been approved in 2014 for lowering blood sugar in adults with type 2 diabetes, but the FDA said that the drug was also "shown to reduce the risk of cardiovascular death."

Source: FactSet

Risk of cardiovascular death is 70 percent higher in adults with diabetes compared to those without, according to the Centers for Disease Control and Prevention. It is also the leading cause of death among adults with type 2 diabetes, said Jean-Marc Guettier, director of the FDA's Division of Metabolism and Endocrinology Products.

"Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes," Guettier said in a statement.

Boehringer Ingelheim CEO Paul Fonteyne said in a statement, "This new indication represents a tremendous step forward in our efforts to reduce the impact of cardiovascular disease among adults with type 2 diabetes and established cardiovascular disease."

Even with Friday's gains, Eli Lilly shares have fallen 19 percent this year.

[Deleted]

Have any insulin analogues been in trials to examine cardiovascular death rates?

[peppy]

Dec 3, 2016 21:38:57 GMT -5 mannmade said:

www.yahoo.com/finance/news/eli-lilly-spikes-fda-approves-212305055.html

Health
Eli Lilly spikes after FDA approves label change for diabetes drug to reduce cardiovascular death
Christine Wang,CNBC Fri, Dec 2 1:23 PM PST

Eli Lilly (LLY) shares climbed amid a volume spike after the Food and Drug Administration approved a label change for a diabetes drug the company markets with German pharmaceutical company Boehringer Ingelheim.

The stock gained more than 2 percent as more than 12.2 million shares changed hands, well above its 30-day average volume of 6.9 million shares.

Jardiance had already been approved in 2014 for lowering blood sugar in adults with type 2 diabetes, but the FDA said that the drug was also "shown to reduce the risk of cardiovascular death."

Source: FactSet

Risk of cardiovascular death is 70 percent higher in adults with diabetes compared to those without, according to the Centers for Disease Control and Prevention. It is also the leading cause of death among adults with type 2 diabetes, said Jean-Marc Guettier, director of the FDA's Division of Metabolism and Endocrinology Products.

"Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes," Guettier said in a statement.

Boehringer Ingelheim CEO Paul Fonteyne said in a statement, "This new indication represents a tremendous step forward in our efforts to reduce the impact of cardiovascular disease among adults with type 2 diabetes and established cardiovascular disease."

Even with Friday's gains, Eli Lilly shares have fallen 19 percent this year.

docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf

The most common adverse reactions associated with JARDIANCE (5%
or greater incidence) were urinary tract infections and female genital
mycotic infections (6.1)

5.3 Acute Kidney Injury and Impairment in Renal Function
JARDIANCE causes intravascular volume contraction [see Warnings and Precautions (5.1)] and can cause
renal impairment [see Adverse Reactions (6.1)]. There have been postmarketing reports of acute kidney injury,
some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including JARDIANCE;
some reports involved patients younger than 65 years of age.
Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury including
hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications (diuretics, ACE
inhibitors, ARBs, NSAIDs). Consider temporarily discontinuing JARDIANCE in any setting of reduced oral
intake (such as acute illness or fasting) or fluid losses (such as gastrointestinal illness or excessive heat
exposure); monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs,
discontinue JARDIANCE promptly and institute treatment.
JARDIANCE increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more
susceptible to these changes. Renal function abnormalities can occur after initiating JARDIANCE [see Adverse
Reactions (6.1)]. Renal function should be evaluated prior to initiation of JARDIANCE and monitored
periodically thereafter. More frequent renal function monitoring is recommended in patients with an eGFR
below 60 mL/min/1.73 m2. Use of JARDIANCE is not recommended when eGFR is persistently less than 45

My words, I am surprised Jardiance helps cardiovascular.

Are side effects that occur under the age of 65 more significant than side effects that occur over the age of 65?

(I have been reading to much about depopulation.)