CDSCO Approves Afrezza® (insulin human) Inhalation Powder in India
MannKind (MNKD) announced that India's Central Drugs Standard Control Organisation (CDSCO) has approved Afrezza (insulin human) Inhalation Powder for adults. This approval follows existing approvals in the United States and Brazil. The company expects to ship the product to their partner Cipla by the end of 2025.
This milestone is particularly significant as India has the second-highest burden of diabetes worldwide, with over 74 million people affected. The partnership between MannKind and Cipla, established in May 2018, involves Cipla handling regulatory approvals, marketing, and sales in India, while MannKind is responsible for product supply.
According to the International Diabetes Federation, diabetes affects 537 million adults globally, with projections reaching 643 million by 2030 and 783 million by 2045.
MannKind (MNKD) ha annunciato che l'Organizzazione Centrale per il Controllo degli Standard dei Farmaci dell'India (CDSCO) ha approvato Afrezza (insulina umana) Polvere Inhalatoria per adulti. Questa approvazione segue le approvazioni esistenti negli Stati Uniti e in Brasile. L'azienda prevede di spedire il prodotto al proprio partner Cipla entro la fine del 2025.
Questo traguardo è particolarmente significativo poiché l'India ha il secondo più alto tasso di diabete al mondo, con oltre 74 milioni di persone colpite. La partnership tra MannKind e Cipla, stabilita nel maggio 2018, prevede che Cipla gestisca le approvazioni normative, il marketing e le vendite in India, mentre MannKind è responsabile della fornitura del prodotto.
Secondo la Federazione Internazionale del Diabete, il diabete colpisce 537 milioni di adulti a livello globale, con proiezioni che raggiungono i 643 milioni entro il 2030 e 783 milioni entro il 2045.
MannKind (MNKD) anunció que la Organización Central de Control de Drogas de la India (CDSCO) ha aprobado Afrezza (insulina humana) en polvo para inhalación para adultos. Esta aprobación sigue a las aprobaciones existentes en Estados Unidos y Brasil. La compañía espera enviar el producto a su socio Cipla para finales de 2025.
Este hito es particularmente significativo ya que la India tiene la segunda carga de diabetes más alta del mundo, con más de 74 millones de personas afectadas. La asociación entre MannKind y Cipla, establecida en mayo de 2018, implica que Cipla maneje las aprobaciones regulatorias, el marketing y las ventas en India, mientras que MannKind es responsable del suministro del producto.
Según la Federación Internacional de Diabetes, la diabetes afecta a 537 millones de adultos a nivel mundial, con proyecciones que alcanzan los 643 millones para 2030 y 783 millones para 2045.
맹킨드 (MNKD)는 인도의 중앙 의약품 표준 관리 기구(CDSCO)가 성인용 아프레자(인간 인슐린) 흡입 분말을 승인했다고 발표했습니다. 이 승인과 함께 미국과 브라질에서의 기존 승인이 이어졌습니다. 회사는 2025년 말까지 제품을 파트너 시프라에 배송할 계획입니다.
이 중요한 이정표는 인도가 전 세계에서 두 번째로 높은 당뇨병 부담을 안고 있으며, 7,400만 명이 넘는 사람들이 영향을 받고 있다는 점에서 특히 의미가 큽니다. 2018년 5월에 설립된 맹킨드와 시프라 간의 파트너십은 시프라가 인도의 규제 승인, 마케팅 및 판매를 처리하고, 맹킨드는 제품 공급을 담당하는 구성을 포함합니다.
국제당뇨병연맹에 따르면, 당뇨병은 전 세계적으로 5억 3,700만 명의 성인에게 영향을 미치며, 2030년까지 6억 4,300만 명, 2045년까지 7억 8,300만 명에 이를 것으로 예상됩니다.
MannKind (MNKD) a annoncé que l'Organisation centrale pour le contrôle des médicaments en Inde (CDSCO) a approuvé Afrezza (insuline humaine) Poudre Inhalée pour les adultes. Cette approbation fait suite aux approbations existantes aux États-Unis et au Brésil. La société s'attend à expédier le produit à son partenaire Cipla d'ici la fin de 2025.
Cette étape est particulièrement significative car l'Inde a le deuxième plus grand fardeau de diabète au monde, avec plus de 74 millions de personnes touchées. Le partenariat entre MannKind et Cipla, établi en mai 2018, prévoit que Cipla s'occupe des approbations réglementaires, du marketing et des ventes en Inde, tandis que MannKind est responsable de l'approvisionnement du produit.
Selon la Fédération internationale du diabète, le diabète touche 537 millions d'adultes dans le monde, avec des projections atteignant 643 millions d'ici 2030 et 783 millions d'ici 2045.
MannKind (MNKD) hat angekündigt, dass die Zentrale Arzneimittelüberwachungsorganisation Indiens (CDSCO) Afrezza (Humansulin) Inhalationspulver für Erwachsene genehmigt hat. Diese Genehmigung folgt auf bestehende Genehmigungen in den USA und Brasilien. Das Unternehmen erwartet, das Produkt bis Ende 2025 an seinen Partner Cipla zu liefern.
Diese Errungenschaft ist besonders bedeutend, da Indien die weltweit zweithöchste Diabeteslast trägt, mit über 74 Millionen betroffenen Menschen. Die Partnerschaft zwischen MannKind und Cipla, die im Mai 2018 gegründet wurde, umfasst, dass Cipla die regulatorischen Genehmigungen, das Marketing und den Vertrieb in Indien übernimmt, während MannKind für die Produktversorgung verantwortlich ist.
Laut der Internationalen Diabetesföderation sind weltweit 537 Millionen Erwachsene von Diabetes betroffen, wobei die Prognosen bis 2030 auf 643 Millionen und bis 2045 auf 783 Millionen steigen.
- Received regulatory approval in India, the world's second-largest diabetes market
- Strategic partnership with established pharmaceutical company Cipla for marketing and distribution
- Access to market of 74+ million diabetes patients in India
- Product commercialization expected by end of 2025
- No revenue generation from Indian market until end of 2025
Insights
The CDSCO approval of Afrezza in India represents a significant market expansion opportunity for MannKind. India's diabetes population of 74 million patients makes it the second-largest diabetes market globally, with substantial growth potential as prevalence is expected to increase. The inhaled insulin delivery system offers a compelling alternative to injectable insulin, which could drive adoption among insulin-dependent diabetics seeking less invasive treatment options.
The partnership with Cipla, a well-established pharmaceutical company in India, provides MannKind with strong local market access and distribution capabilities. While revenue impact won't be immediate due to the 2025 projected shipping timeline, this approval opens up a massive new market that could significantly boost MannKind's long-term growth trajectory and global footprint in diabetes care.
This regulatory milestone unlocks significant revenue potential for MannKind in one of the world's largest diabetes markets. The partnership with Cipla minimizes market entry risks and operational costs while leveraging established local distribution networks. The 2025 commercialization timeline allows for proper manufacturing scale-up and supply chain preparation.
While specific revenue projections aren't provided, India's large diabetic population and growing middle class suggest substantial market opportunity. The agreement's structure, with MannKind handling manufacturing and Cipla managing local operations, should enable healthy margins. This approval strengthens MannKind's global expansion strategy and diversifies revenue streams beyond U.S. operations.
- India has the 2nd highest burden of diabetes worldwide
- CDSCO decision follows existing approvals in the U.S.A. and Brazil
- MannKind expects to ship product for Cipla Ltd. by end of 2025
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- 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 Afrezza
Afrezza (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 MannKind
MannKind 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 Statements
This 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.
FAQ
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