The official blog of the Lung Institute.

FDA Fast-tracks 2 New Medications to Treat Pulmonary Fibrosis

10 Jul 2015
| Under Lung Disease | Posted by | 8 Comments

Ofev and Esbriet

Two medications, Ofev and Esbriet, were recently fast-tracked for approval by the U.S. Food and Drug Administration (FDA) to treat idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis is a progressive lung disease typically caused by occupational and environmental factors, a response from medications, autoimmune disorders, infections, genetics and other unknown factors. IPF refers to pulmonary fibrosis with no known cause. Smoking is known to exacerbate this condition. Until recently, this disease was considered untreatable. However, today, these new medications combined with cellular therapy allow IPF sufferers a new lease on life.

Both Ofev (nintedanib) and Esbriet (pirfenidone) help prevent further lung tissue scarring, and a study showed that the medication allowed patients to exhale significantly more breath than those who were given a placebo. The most common side effects of Ofev and Esbriet include nausea, coughing, diarrhea and high blood pressure. Neither drug is recommended for those who suffer from liver conditions.

Looking Ahead

These drugs effectively slow the progression of IPF, therefore helping to bridge the gap between now and a future cure. Patients who were previously given a death sentence now have the opportunity to extend their lives, hopefully long enough to see a cure. Used in conjunction with cellular therapy, these drugs allow IPF sufferers the freedom to explore treatment options that are effective and improve their quality of life. Like Ofev and Esbriet, cellular therapy can stop the progression of IPF, and, even better, has the potential to promote healing. While neither the medications nor cellular therapy are a cure for IPF, both provide the opportunity for an improved quality of life. It gives patients options.

Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, commented on the new medication approvals: “Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”

Cellular Therapy

Finding an appropriate treatment option is key when suffering from a debilitating lung disease like IPF. Rather than simply accepting traditional options that only treat symptoms, many patients have already shifted from the complacent healthcare norms to seek out alternative treatment options like cellular therapy. Now, the industry is catching up with the approval of these two medications.

The Lung Institute is a cellular clinic in the United States that specializes in treating those who suffer from lung diseases like IPF. The treatment is a three day, minimally-invasive outpatient procedure. Cells are harvested from a patient’s blood, fat or bone marrow, processed, and then reintroduced into the body. This procedure speeds up the body’s natural healing process by directing cells to damaged tissue. Rather than treating symptoms, it treats the damaged tissue itself.

The Lung Institute is excited about the approval of these medications to treat IPF, which, until recently, was completely incurable. While there still isn’t a cure, Ofev, Esbriet and cellular therapy are bringing us closer to it, allowing those with IPF to breathe easier. If you or a loved one are suffering from IPF, the Lung Institute might be able to help. Contact one of our patient coordinators today at (800) 729-3065.


  1. Lung Institute

    7 months ago


    Thank you for your comment and we wish you well with your Esbriet treatment.

    In order to determine if someone is a candidate for treatment, we need to gather more of their private medical history in a secure setting. The best way to do that is by giving us a call and speaking one-on-one with someone on our medical team over our secure phone line. We’re happy to answer your questions about cells, treatment options, candidacy and cost. So, feel free to contact us at (855) 313-1149. We look forward to hearing from you soon.


    The Lung Institute

  2. Adi M Maneckshaw

    7 months ago

    I am about to start esbriet treatment.
    There are more nagatives about the treatment: 1. Liver damage 2. Sensitive to sun. 3. And many more nauseau, diarrhea, blood pressure, etc.
    total # of people cured Or are under treatment are only 142 k.
    So why Drs/ enchantmentor esbriet pushing so hard for an individual to start The trEatment? Are drs getting paId bt the company?
    Thanks appreciate y res?
    Adi manecksHaw

  3. Matt

    1 year ago

    Hello Layla,
    Thank you for your question. We do treat pulmonary fibrosis with cell therapy at the Lung Institute. The Lung Institute operates five clinics in the United States including Pittsburgh, PA; Nashville, TN; Tampa, FL; Dallas, TX; and Scottsdale, AZ. For more information, please give us a call at (855) 313-1149. Thanks again and have a great day.

  4. Layla

    1 year ago

    My mother is from the netherlands, she is diagnosist with lungfibroses can she also do the treatment?

  5. PB

    1 year ago

    Dear Dr. Guy Parent,

    Thanks for your comment. Stem cell treatment cost varies depending on treatment type. So, to answer your question in more detail, it’s best to contact us at (855) 313-1149 to speak one-on-one with a patient coordinator. Our patient coordinators have a wealth of knowledge about cellular therapy, treatment options, candidacy and cost, and they are happy to answer your questions. We look forward to hearing from you soon.

    Kind Regards,

    The Lung Institute

  6. Dr Guy Parent

    1 year ago

    How much approximately could that cost? Stem cells treatments for COPD?

  7. PB

    2 years ago

    Dear Thomas,

    Unfortunately, at this time, Medicare doesn’t cover treatment. However, we’re hopeful that treatment will be covered by Medicare and insurance companies in the near future. Keep in mind that it will take some time before the insurance companies and Medicare see a financial benefit in their favor and then decide to cover it. In the meantime, you can learn more about cellular treatment options and have your questions answered by one of our patient coordinators. Feel free to contact us at (855) 313-1149 for more information. We look forward to hearing from you soon.

    Best Regards,

    The Lung Institute

  8. Thomas Loft

    2 years ago

    Is the cell procedure cost coveted by Medicare?

All claims made regarding the efficacy of Lung Institute's treatments as they pertain to pulmonary conditions are based solely on anecdotal support collected by Lung Institute. Individual conditions, treatment and outcomes may vary and are not necessarily indicative of future results. Testimonial participation is voluntary. Lung Institute does not pay for or script patient testimonials.

As required by Texas state law, the Lung Institute Dallas Clinic has received Institutional Review Board (IRB) approval from MaGil IRB, now Chesapeake IRB, which is fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP), for research protocols and procedures. The Lung Institute has implemented these IRB approved standards at all of its clinics nationwide. Approval indicates that we follow rigorous standards for ethics, quality, and protections for human research.