Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, along with its subsidiaries together referred to as “Dr.
Reddy’s”) today announced approval of ELYXYB (celecoxib oral
solution 25 mg/mL) by the U.S. Food and Drug Administration
(USFDA). ELYXYB (previously known as DFN-15) is indicated for the
acute treatment of migraine with or without aura in adults. ELYXYB
is the latest product emerging from Dr. Reddy’s portfolio of
successful acute migraine treatments. The company is working to
commercialize this product through partners.
Erez Israeli, CEO of Dr. Reddy’s Laboratories, commented, “We
are excited about the approval of ELYXYB. It reaffirms our
commitment to innovation and to develop meaningfully differentiated
products that address significant unmet needs of patients and
physicians, leading to better health outcomes.”
According to Anil Namboodiripad, PhD, Sr. Vice President of the
Proprietary Products Group, Dr. Reddy’s Laboratories, “ELYXYB is an
oral solution of celecoxib formulated using a self-micro
emulsifying drug delivery system that improves solubility and
bioavailability of the drug leading to better absorption1. This
allows for administration of a lower dose without affecting
bioavailability. In pivotal studies, ELYXYB demonstrated a rapid
onset of action which is critically important to patients suffering
from acute migraine attacks. The results from pivotal studies with
ELYXYB established efficacy of celecoxib in the treatment of
migraine with very few adverse events. For patients who suffer from
the debilitating and disruptive effects of migraine, there
continues to be a need for reliable and efficacious treatment
options. ELYXYB’s oral solution dosage form makes it convenient for
patients to take it immediately upon emergence of migraine
attacks.”
INDICATION AND USAGE
ELYXYB is indicated in adults for the acute treatment of
migraine with or without aura.
Limitations of Use:
- ELYXYB is not indicated for the preventive treatment of
migraine.
IMPORTANT SAFETY INFORMATION:
WARNING: RISK OF SERIOUS
CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular
Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an
increased risk of serious cardiovascular thrombotic events,
including myocardial infarction and stroke, which can be fatal.
This risk may occur early in the treatment and may increase with
duration of use [see Warnings and Precautions (5.1)].
- ELYXYB is contraindicated in the setting of coronary artery
bypass graft (CABG) surgery [see Contraindications (4) and Warnings
and Precautions (5.1)].
Gastrointestinal
Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal
(GI) adverse events including bleeding, ulceration, and perforation
of the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elderly
patients and patients with a prior history of peptic ulcer disease
and/or GI bleeding are at greater risk for serious (GI) events [see
Warnings and Precautions (5.2)].
ELYXB is contraindicated in patients with:
- Known hypersensitivity to celecoxib, any components of the drug
product, or sulfonamides (4)
- History of asthma, urticaria, or other allergic-type reactions
after taking aspirin or other NSAIDs (4)
- In the setting of CABG surgery (4)
To minimize the potential risk for an adverse cardiovascular
(CV) event in NSAID-treated patients, use ELYXYB for the fewest
number of days per month as needed, based on individual treatment
goals. Physicians and patients should remain alert for the
development of such events, throughout the entire treatment course,
even in the absence of previous CV symptoms. Patients should be
informed about the symptoms of serious CV events and the steps to
take if they occur.
Avoid the use of ELYXYB in patients with a recent myocardial
infarction (MI) unless the benefits are expected to outweigh the
risk of recurrent CV thrombotic events. If ELYXYB is used in
patients with a recent MI, monitor patients for signs of cardiac
ischemia.
NSAIDs, including ELYXYB, can cause serious gastrointestinal
(GI) adverse events including inflammation, bleeding, ulceration,
and perforation of the esophagus, stomach, small intestine, or
large intestine, which can be fatal. These serious adverse events
can occur at any time, with or without warning symptoms, in
patients treated with celecoxib. Only one in five patients who
develop a serious upper GI adverse event on NSAID therapy is
symptomatic. Upper GI ulcers, gross bleeding, or perforation caused
by NSAIDs occurred in approximately 1% of patients treated for 3 to
6 months, and in about 2% to 4% of patients treated for one year.
However, even short-term NSAID therapy is not without risk.
Avoid the use of ELYXYB in patients with severe heart failure
unless the benefits are expected to outweigh the risk of worsening
heart failure. If ELYXYB is used in patients with severe heart
failure, monitor patients for signs of worsening heart failure.
Elevations of ALT or AST (less than three times ULN) may occur
in up to 15% of patients treated with NSAIDs, including ELYXYB.
Long-term administration of NSAIDs, including celecoxib, the
active ingredient in ELYXYB, has resulted in renal papillary
necrosis and other renal injury.
No information is available from controlled clinical studies
regarding the use of celecoxib in patients with severe renal
impairment. The renal effects of celecoxib may hasten the
progression of renal dysfunction in patients with preexisting renal
disease.
Overuse of acute migraine drugs (e.g., ergotamine, triptans,
opioids, nonsteroidal anti-inflammatory drugs or combination of
these drugs for 10 or more days per month), including ELYXYB, may
lead to exacerbation of headache (medication overuse headache).
Medication overuse headache may present as migraine-like daily
headaches or as a marked increase in frequency of migraine attacks.
Detoxification of patients, including withdrawal of the overused
drugs and treatment of withdrawal symptoms (which often includes a
transient worsening of headache) may be necessary.
NSAIDs, including ELYXYB, may increase the risk of bleeding
events. Co-morbid conditions such as coagulation disorders or
concomitant use of warfarin, other anticoagulants, antiplatelet
drugs (e.g., aspirin), SSRIs, and serotonin norepinephrine reuptake
inhibitors (SNRIs) may increase this risk.
Most common adverse reaction (at least 3% and greater than
placebo) is dysgeusia.
These are not all the side effects associated with ELYXYB.
Please see Patient Information, Instructions For Use, Medication
Guide and Full Prescribing Information for ELYXYB
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf).
You are encouraged to report negative side effects of
prescription drugs. To report SUSPECTED SIDE EFFECTS, call Promius
Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088
(1-800-332-1088) or online at
http://www.fda.gov/Safety/MedWatch
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical
company, committed to providing affordable and innovative medicines
for healthier lives. Through its three businesses - Pharmaceutical
Services & Active Ingredients, Global Generics and Proprietary
Products – Dr. Reddy’s offers a portfolio of products and services
including APIs, custom pharmaceutical services, generics,
biosimilars and differentiated formulations. Our major therapeutic
areas of focus are gastrointestinal, cardiovascular, diabetology,
oncology, pain management and dermatology. Dr. Reddy’s operates in
markets across the globe. Our major markets include – USA, India,
Russia & CIS countries, and Europe. For more information, log
on to: www.drreddys.com
Disclaimer: This press release may include statements of
future expectations and other forward-looking statements that are
based on the management’s current views and assumptions and involve
known or unknown risks and uncertainties that could cause actual
results, performance or events to differ materially from those
expressed or implied in such statements. In addition to statements
which are forward-looking by reason of context, the words "may",
"will", "should", "expects", "plans", "intends", "anticipates",
"believes", "estimates", "predicts", "potential", or "continue" and
similar expressions identify forward-looking statements. Actual
results, performance or events may differ materially from those in
such statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults , currency exchange rates , interest rates , persistency
levels and frequency / severity of insured loss events (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, (vi) the susceptibility of
our industry and the markets addressed by our, and our customers’,
products and services to economic downturns as a result of natural
disasters, epidemics, pandemics or other widespread illness,
including coronavirus (or COVID-19), and (vii) other risks and
uncertainties identified in our public filings with the Securities
and Exchange Commission, including those listed under the "Risk
Factors" and "Forward-Looking Statements" sections of our Annual
Report on Form 20-F for the year ended March 31, 2019.
The company assumes no obligation to update any information
contained herein.
1 Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal,
Jing Niu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical
Drug Investigation volume 37, pages 937–946(2017)
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135)
MEDIA RELATIONS APARNA TEKURI aparnatekuri@drreddys.com
(PH: +91-40-49002446)
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