CDSCO Approves Afrezza® (insulin human) Inhalation Powder in India
11 12월 2024 - 8:00PM
MannKind Corporation (Nasdaq: MNKD), a company
focused on the development and commercialization of innovative
inhaled therapeutic products and devices for patients with
endocrine and orphan lung diseases, and Cipla Ltd. announced today
that the Central Drugs Standard Control Organisation (CDSCO) in
India has approved Afrezza (insulin human) Inhalation Powder in
adults. The CDSCO decision follows existing approvals in the United
States and Brazil.
“Achieving approval for Afrezza in India, a country with the
second highest burden of diabetes worldwide, is an exciting
milestone for MannKind and our partner Cipla,” said Michael
Castagna, PharmD, Chief Executive Officer for MannKind Corporation.
“We are excited for Cipla to market the first inhaled insulin
treatment option for adults living with diabetes in India and
expect to prepare product for export by the end of 2025.”
MannKind entered into an exclusive marketing and distribution
agreement for Afrezza in India with Cipla Ltd., a global
pharmaceutical company, in May 2018. Under the terms of the
agreement, Cipla was responsible for obtaining regulatory approvals
to distribute Afrezza in India as well as marketing and sales
activities. MannKind is responsible for supplying Afrezza to
Cipla.
“The availability of Afrezza has the potential to help so many
people in India living with diabetes in improving glycemic control
via a non-injectable and convenient delivery of inhaled insulin,”
said Dr. Satish Garg, MBBS, DM, Professor of Medicine and
Pediatrics at the Adult Clinic of the Barbara Davis Center for
Diabetes of the University of Colorado School of Medicine in
Denver.
The International Diabetes Federation (IDF) reported in 2021
that diabetes mellitus affects 537 million adults (20-79 years of
age) worldwide, including more than 74 million people in India. IDF
estimations are that the total number of people living with
diabetes is projected to rise to 643 million by 2030 and 783
million by 2045.
About AfrezzaAfrezza (insulin human) Inhalation
Powder is a rapid-acting inhaled human insulin indicated to improve
glycemic control in adults with diabetes mellitus.
Limitations of Use: Not recommended for the treatment of
diabetic ketoacidosis or in patients that smoke or have recently
stopped smoking.
Important Safety Information
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC
LUNG DISEASE
- Acute bronchospasm has been observed in Afrezza-treated
patients with asthma and COPD.
- Afrezza is contraindicated in patients with chronic lung
disease such as asthma or COPD.
- Before initiating Afrezza, perform a detailed medical history,
physical examination, and spirometry (FEV1) to identify potential
lung disease in all patients.
Most common adverse reactions are hypoglycemia, cough, and
throat pain or irritation.
Please see additional Important Safety Information, Full
Prescribing Information, including BOXED WARNING, available on
Afrezza.com/safety.
About MannKindMannKind Corporation (Nasdaq:
MNKD) focuses on the development and commercialization of
innovative inhaled therapeutic products and devices to address
serious unmet medical needs for those living with endocrine and
orphan lung diseases.
We are committed to using our formulation capabilities and
device engineering prowess to lessen the burden of diseases such as
diabetes, nontuberculous mycobacterial (NTM) lung disease,
pulmonary fibrosis, and pulmonary hypertension. Our signature
technologies – dry-powder formulations and inhalation devices –
offer rapid and convenient delivery of medicines to the deep lung
where they can exert an effect locally or enter the systemic
circulation, depending on the target indication.
With a passionate team of Mannitarians collaborating nationwide,
we are on a mission to give people control of their health and the
freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on
LinkedIn, Facebook, X or Instagram.
Forward-Looking StatementsThis press release
contains forward-looking statements about the estimated shipment of
product that involves risks and uncertainties. Words such as
“believes”, “anticipates”, “plans”, “expects”, “intends”, “will”,
“goal”, “potential” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon MannKind’s current expectations. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
manufacturing risks that may adversely affect our ability to
manufacture our products as well as other risks detailed in
MannKind’s filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K for the year ended
December 31, 2023, and subsequent periodic reports on Form 10-Q and
current reports on Form 8-K. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date of this press release. All forward-looking statements
are qualified in their entirety by this cautionary statement, and
MannKind undertakes no obligation to revise or update any
forward-looking statements to reflect events or circumstances after
the date of this press release.
CIPLA is a registered trademark of Cipla, Ltd.
AFREZZA and MANNKIND are registered trademarks of MannKind
Corporation.
For MannKind:
Media Relations
Christie Iacangelo
(818) 292-3500
Email: media@mnkd.com
Investor Relations
Ana Kapor
(818) 661-5000
Email: ir@mnkd.com
MannKind (NASDAQ:MNKD)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
MannKind (NASDAQ:MNKD)
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부터 12월(12) 2023 으로 12월(12) 2024