New Data on FORTEO® (teriparatide [rDNA origin] injection) Showed Reduced Risk for New Vertebral and Clinical Fractures in Postmenopausal Women with Severe Osteoporosis

First trial in osteoporosis research that has shown a significant fracture reduction outcome as a primary endpoint in a head-to-head, active-drug comparative study.

INDIANAPOLIS, Nov. 9, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data showing that treatment with FORTEO® for 24 months was associated with significantly fewer vertebral and clinical fractures (a composite of painful vertebral and non-vertebral fractures) compared with risedronate, a widely used oral bisphosphonate, in postmenopausal women with severe osteoporosis in the VERO clinical trial. Study results are published in the November 9 issue of The Lancet.1

Results from the study's primary endpoint showed that at 24 months, fewer patients taking FORTEO® had new vertebral fractures as compared to patients taking risedronate (5.4% vs. 12.0%, p < 0.0001).

The two year randomized, double-blind, double-dummy clinical trial compared subcutaneous daily teriparatide (20 μg) with oral weekly risedronate (35 mg) in 1,360 women with at least two moderate or one severe vertebral fracture and low bone mass.

"The VERO study data reinforces the efficacy of FORTEO® in reducing fractures and can help physicians make informed prescribing decisions," said David L. Kendler, Professor of Endocrinology in the University of British Columbia, Vancouver and first author of the article.

This is the first trial in osteoporosis research that has shown a significant fracture reduction outcome as a primary endpoint in a head-to-head, active-drug comparative study.

After 24 months of treatment:

FORTEO® is a prescription medication used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones, or fractures.2 FORTEO® is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones, or fractures. FORTEO® can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.

During the drug testing process, the medicine in FORTEO® caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took FORTEO®, and it is unknown if people who take FORTEO® have a higher chance of getting the disease. Before patients take FORTEO®, patients should tell their healthcare provider if they have Paget's disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy. For more information about FORTEO®, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.

About the Study
"Effects of 24 months treatment of teriparatide compared with risedronate on new fractures in postmenopausal women with severe osteoporosis: a randomized, double-dummy, clinical trial" (Study B3D-EW-GHDW [VERO Study]) was a Phase 4, multinational, multicenter, prospective, randomized, parallel, active comparator, clinical trial.

The primary endpoint was the incidence of new vertebral fractures after two years assessed by quantitative morphometry. Secondary outcomes were clinical fractures, non-vertebral fractures, other spine fractures endpoints, height loss, back pain, quality of life (EQ-5D) and safety. Adverse events and safety laboratory findings were consistent with the known safety profile of each drug.

1,360 patients were randomized to receive either teriparatide 20 μg/day injection (FORTEO®) plus weekly oral placebo or oral risedronate 35 mg/week plus daily placebo injection for a 24-month, double-blind, double dummy treatment phase in study sites from 14 participant countries in Europe, North America (USA and Canada) and South America (Argentina and Brazil). Patients were postmenopausal women over 45 years of age with a BMD T-score < -1.5 standard deviations at the femoral neck, total hip or lumbar spine, and at least two moderate or one severe prevalent vertebral fragility fractures.

Overall, 72·1% of patients had received at least one prior osteoporosis medication, most commonly a bisphosphonate.

Important Safety Information about FORTEO

Read this Medication Guide before you start taking FORTEO and each time you get a refill. There may be new information. Also, read the User Manual that comes with the FORTEO delivery device (pen) for information on how to use the device to inject your medicine the right way. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about FORTEO?

  1. Possible bone cancer. During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.
  2. You should not take FORTEO for more than 2 years over your lifetime.
  3. There is a voluntary Patient Registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.rti.org.

What is FORTEO?

It is not known if FORTEO is safe and effective in children.
FORTEO should not be used in children and young adults whose bones are still growing.

Who should not use FORTEO?

Do not use FORTEO if you:

What should I tell my healthcare provider before taking FORTEO?
Before you take FORTEO, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking FORTEO with other medicines that may harm you.

How should I use FORTEO?

Follow your healthcare provider's instructions about other ways you can help your osteoporosis, such as exercise, diet, and reducing or stopping your use of tobacco and alcohol. If your healthcare provider recommends calcium and vitamin D supplements, you can take them at the same time you take FORTEO.

What are the possible side effects of FORTEO?

FORTEO can cause serious side effects including:

Common side effects of FORTEO include:

Your healthcare provider may take samples of blood and urine during treatment to check your response to FORTEO. Also, your healthcare provider may ask you to have follow-up tests of bone mineral density.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FORTEO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FORTEO?

Keep FORTEO and all medicines out of the reach of children.

General information about FORTEO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORTEO for a condition for which it was not prescribed. Do not give FORTEO to other people, even if they have the same condition you have.

This Medication Guide summarizes the most important information about FORTEO. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FORTEO that is written for healthcare professionals. For more information, go to www.FORTEO.com or call Lilly at 1-866-436-7836.

What are the ingredients in FORTEO?

Active ingredient: teriparatide

Inactive ingredients: glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.

What is Osteoporosis?

Osteoporosis is a disease in which the bones become thin and weak, increasing the chance of having a broken bone. Osteoporosis usually causes no symptoms until a fracture happens. The most common fractures are in the spine (backbone). They can shorten height, even without causing pain. Over time, the spine can become curved or deformed and the body bent over. Fractures from osteoporosis can also happen in almost any bone in the body, for example, the wrist, rib, or hip. Once you have had a fracture, the chance for more fractures greatly increases.

The following risk factors increase your chance of getting fractures from osteoporosis:

This Medication Guide has been approved by the U.S. Food and Drug Administration.
*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company.

For more safety information, please see Medication Guide (http://pi.lilly.com/us/forteo-medguide.pdf) and Prescribing Information (http://pi.lilly.com/us/forteo-pi.pdf) in the USA or the Summary of Product Characteristics  EU (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000425/WC500027994.pdf), including Boxed Warning regarding osteosarcoma. Please see full user manual that accompanies the delivery device.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

P-LLY

FORTEO® is a registered trademark of Eli Lilly and Company

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about FORTEO as a potential treatment for patients with severe osteoporosis, and reflects Lilly's current belief.  However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that FORTEO will continue to be commercially successful.  For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1 The Lancet, Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomized controlled trial. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32137-2/fulltext?elsca1=tlxpr. Accessed November 9, 2017.
2 FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf

Refer to: Scott MacGregor; jsmacgregor@lilly.com; (317) 440-4699 (Lilly)    

 

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

 

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