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FDA Issues Not-Approvable Letter For Lilly's Zyprexa(R) Long-Acting Injection (LAI) For Schizophrenia Treatment
Eli Lilly and Company
(NYSE: LLY) has received a not approvable letter from the U.S. Food and
Drug Administration for Zyprexa(R) long-acting injection (olanzapine LAI)
for the treatment and maintenance treatment of schizophrenia in adults, the
company announced. Zyprexa LAI is an investigational formulation that
combines the atypical antipsychotic medication Zyprexa (olanzapine) with a
pamoate salt, resulting in an extended delivery of up to four weeks.
In its letter, the FDA said it needs more information to better
understand the risk and underlying cause of excessive sedation events that
have been observed in about 1 percent of patients in clinical trials. These
events were discussed during the FDA's Feb. 6 Psychopharmacologic Drugs
Advisory Committee hearing. At the conclusion of that meeting, the
committee voted that there were circumstances under which Zyprexa LAI would
be acceptably safe and effective for the treatment of acutely exacerbated
schizophrenia and maintenance treatment of schizophrenia in adults.
In its letter, however, the FDA cited a new excessive sedation event
that occurred shortly before the Feb. 6 hearing. Lilly alerted the agency
and the advisory committee about the existence of a possible new case on
Feb. 6, noting that Lilly was investigating the details of the event
including conflicting information about the time of onset. After collecting
additional information, Lilly was able to confirm after the advisory
committee hearing that this was a case of excessive sedation and that it
began between 3 to 5 hours after injection. All previous excessive sedation
events had begun within three hours of injection. As with all previous
patients with excessive sedation, this patient fully recovered.
"We are disappointed by the FDA's decision and we are committed to
ongoing discussions to better understand the agency's perspective regarding
this recent case of excessive sedation and to define the path forward and
the associated timeline," said Dr. Jennifer Stotka, Vice President of U.S.
Regulatory Affairs, Eli Lilly and Company. "Given the chronic and severe
nature of schizophrenia, persistent challenges with adherence, and the
limited number of approved depot formulations, we continue to believe that,
if approved, Zyprexa LAI would provide a valuable treatment option for
patients suffering from schizophrenia."
Independent regulatory reviews of Zyprexa LAI applications are ongoing
in the European Union and other countries including Canada and Australia.
About Long-acting Injectable Antipsychotic Medications
Long-acting antipsychotics have been associated with improved treatment
adherence and reduced treatment failures.(i) By administering long-acting
medications, healthcare professionals know when patients have received
their medication and can immediately detect non-adherence when a patient
fails to return for a scheduled injection.(ii) Different from both oral and
injected short-acting formulations, long-acting antipsychotics allow for
stable concentrations of the active drug to remain at a therapeutic range
for an extended period of time.(iii)
About Schizophrenia
Schizophrenia is a severe and debilitating illness often characterized
by acute psychotic episodes including delusions (false beliefs that cannot
be corrected by reason), hallucinations (usually in the form of
non-existent voices or visions) and long-term impairments such as
diminished emotion, lack of interest and depressive symptoms, such as
hopelessness and suicidal thoughts. In addition to these symptoms, patients
with schizophrenia are at greater risk for medical comorbidities than the
general population.
About Oral Zyprexa
Zyprexa is indicated in the United States for the short- and long-term
treatment of schizophrenia, acute mixed and manic episodes of bipolar
disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was
introduced in 1996, it has been prescribed to approximately 24 million
people worldwide. Zyprexa is not approved for patients under 18 years of
age.
Zyprexa is not approved for the treatment of patients with
dementia-related psychosis. Elderly patients with dementia-related
psychosis treated with atypical antipsychotic drugs are at an increased
risk of death compared with those patients taking a placebo.
In addition, compared to elderly patients with dementia-related
psychosis taking a placebo, there was a significantly higher incidence of
cerebrovascular adverse events in elderly patients with dementia-related
psychosis treated with Zyprexa.
Hyperglycemia, in some cases extreme and associated with ketoacidosis
or hyperosmolar coma or death, has been reported in patients treated with
atypical antipsychotics, including Zyprexa.
While relative risk estimates are inconsistent, the association between
atypical antipsychotics and increases in glucose levels appears to fall on
a continuum and olanzapine appears to have a greater association than some
other atypical antipsychotics. Physicians should consider the risks and
benefits when prescribing olanzapine to patients with an established
diagnosis of diabetes mellitus, or who have borderline increased blood
glucose level. Patients taking olanzapine should be monitored regularly for
worsening of glucose control. Persons with risk factors for diabetes who
are starting on atypical antipsychotics should undergo baseline and
periodic fasting blood glucose testing. Patients who develop symptoms of
hyperglycemia during treatment should undergo fasting blood glucose
testing.
Undesirable alterations in lipids have been observed with olanzapine
use. Clinical monitoring, including baseline and follow-up lipid
evaluations in patients using olanzapine, is advised. Significant, and
sometimes very high, elevations in triglyceride levels have been observed
with olanzapine use. Modest mean increases in total cholesterol have also
been seen with olanzapine use.
Potential consequences of weight gain should be considered prior to
starting olanzapine. Patients receiving olanzapine should receive regular
monitoring of weight.
As with all antipsychotic medications, a rare and potentially fatal
condition known as NMS has been reported with Zyprexa. If signs and
symptoms appear, immediate discontinuation is recommended. Clinical
manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental
status and evidence of autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional
signs may include elevated creatinine phosphokinase, myoglobinuria
(rhabdomyolysis), and acute renal failure.
Also, as with all antipsychotic treatment, prescribing should be
consistent with the need to minimize Tardive Dyskinesia (TD). The risk of
developing TD and the likelihood that it will become irreversible are
believed to increase as the duration of treatment and the total cumulative
dose of antipsychotic increase. The syndrome may remit, partially or
completely, if antipsychotic treatment is withdrawn.
The most common treatment-emergent adverse event associated with
Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania
trials was somnolence. Other common events were dizziness, weight gain,
personality disorder (COSTART term for nonaggressive objectionable
behavior), constipation, akathisia, postural hypotension, dry mouth,
asthenia, dyspepsia, increased appetite and tremor.
Full prescribing information, including a boxed warning, is available
at http://www.zyprexa.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class 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. Additional
information about Lilly is available at http://www.lilly.com.
P-LLY
This press release contains forward-looking statements about the safety
and efficacy of ZYPREXA Long Acting Injection (LAI) and reflects Lilly's
current beliefs. However, there are substantial risks and uncertainties in
the process of research, development, regulatory approvals, and
commercialization. There is no guarantee that ZYPREXA LAI will be approved
for the treatment of schizophrenia or that if approved, it will 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.
References
(i) Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics
prescribed more often and what can be done about it? Advances in
Psychiatric Treatment (2005) 11: 203-211.
(ii) Kane J.M et al. Guidelines for depot antipsychotic treatment in
schizo- phrenia. European Neuropsychopharmacology, Volume 8, Number
1, 1 February 1998, pp. 55-66(12). p. 58.
(iii) Maxine X. Patel and Anthony S. David. Why aren't depot
antipsychotics prescribed more often and what can be done about
it? Advances in Psychiatric Treatment (2005) 11: 203-211.
Eli Lilly and Company
http://www.lilly.com
View drug information on Zyprexa.
FDA Probleme Nu-Approvable scrisoare pentru Lilly's Zyprexa (R) cu acþiune de lungã duratã de injectie (Lai) Pentru Tratamentul Schizofrenie - FDA Issues Not-Approvable Letter For Lilly's Zyprexa(R) Long-Acting Injection (LAI) For Schizophrenia Treatment - articole medicale engleza - startsanatate